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Dotatate

Dotatate, also known as 68Ga-DOTA-TOC, is a radiopharmaceutical used for the imaging and treatment of neuroendocrine tumors.
It consists of a somatostatin analog (DOTA-TOC) labeled with the positron-emitting radionuclide gallium-68.
Dotatate binds to somatostatin receptors, which are overexpressed on the surface of many neuroendocrine tumors, allowing for the visualization and quantification of these tumors using positron emission tomography (PET) imaging.
Additionally, dotatate can be used for targeted radionuclide therapy of somatostatin receptor-positive tumors.
The use of dotatate has demonstrated high diagnostic accuracy and therapeutic efficacy in the management of neuroendocrine malignancies.
Reserchers can optimie their dotatate studies using the AI-driven PubCompare.ai platform, which helps identify the most accurate and reproducible protocols from literature, preprints, and patents.

Most cited protocols related to «Dotatate»

Line sources with 177Lu solutions (0.3 MBq/ml) were prepared and measured in air at three different distances (5, 10, and 15 cm) from the gamma camera collimator. The gamma camera used for generating planar and SPECT/CT images was a Millennium VG Hawkeye (General Electric Medical Systems, Milwaukee, WI, USA), equipped with a medium-energy parallel-hole collimator. A 20% energy window over the 208 keV photon peak was used. A 1024 × 1024 matrix was used for the gamma camera measurement of the line sources. The SPECT image acquisition used the same energy setting as above. The clinical SPECT images of patients, injected with 7.4 GBq 177Lu-DOTATATE, were collected 24 h post-injection, with a 30-s frame time duration for 120 projections. The matrix size was 128 × 128 with a pixel size of 4.42 mm and a slice thickness of 4.42 mm. The CT images were acquired using a 140-kV tube voltage, 2.5 mAs, and a rotation speed of 2.6 rpm. The matrix size was 512 × 512 with a pixel size of 0.98 mm and a slice thickness of 5 mm.
The Jaszczak image quality phantom was used to evaluate the performance of the MC OSEM reconstruction (SARec-OSEM) in comparison with standard clinical attenuated corrected OSEM reconstructions (AC-OSEM) and clinical state-of-the-art OSEM reconstructions with resolution recovery corrections (RRC-OSEM). A 256 × 256 matrix was used in this evaluation. The six spheres and the background in the Jaszczak phantom were filled with an activity concentration of 300 and 12 kBq/ml, respectively. Thereby, the activity concentration ratio between the spheres and the background was equal to 25, which is in the order of the tumor-to-normal tissue ratios observed in patients [32 (link)]. The activity recovery, i.e., the normalized signal-to-background ratio (SBR) and signal-to-noise ratio (SNR), were measured. The signal in the different sphere sizes was measured within a volume of interest (VOI) equal in size to the spheres. The mean background and the standard deviation of the background were measured in 19 VOIs, equal in size to the signal VOI, and placed in the central plane of the phantom.
Publication 2018
Electricity Gamma Cameras Lutetium-177 lutetium Lu 177 dotatate Neoplasms Patients Reading Frames Reconstructive Surgical Procedures Single Photon Emission Computed Tomography Computed Tomography Tissues Tomography, Emission-Computed, Single-Photon
We calculated the required number of patients for the trial assuming that the median progression-free survival would be 30 months in the 177Lu-Dotatate group and 14 months in the control group, the study would have 90% nominal power at an alpha level of 5%, and the prespecified enrollment period and follow-up period for both groups would be 18 months. On the basis of those assumptions, we calculated that we needed a sample of 124 patients, and the analysis of the primary end point was planned to be conducted after at least 74 events of disease progression or death that were centrally confirmed and could be evaluated had occurred. However, the sample size of the trial was adjusted to 230 patients to enable us to detect a statistically significant and clinically relevant difference between the two treatment groups in overall survival as a secondary end point. This calculation was based on the assumption that the median overall survival would be 50 months in the 177Lu-Dotatate group and 32 months in the control group, with 80% nominal power at an alpha level of 5%, and a prespecified enrollment period of 18 months and a long-term follow-up period of 60 months. A prespecified interim analysis of overall survival was conducted at the time of the analysis of progression-free survival. The final analysis of overall survival is planned to be performed either after 158 deaths have occurred or 5 years after the last patient underwent randomization, whichever occurs first.
All patients who underwent randomization were included in the analyses of efficacy, demographics, and baseline characteristics. The safety population, which comprised all patients who underwent randomization and received at least one dose of trial treatment, was used for all safety analyses. The median point estimate and 95% confidence interval for progression-free survival and overall survival were estimated by means of the Kaplan–Meier method. Objective response rates and corresponding 95% confidence intervals were calculated for each treatment group and were compared with the use of Fisher's exact test. Survival curves were compared with the use of an unstratified log-rank test and were tested against the null hypothesis. Hazard ratios were estimated with the use of an unstratified Cox proportional-hazards model.
Publication 2017
Disease Progression lutetium Lu 177 dotatate Patients Safety
This international, multicenter, phase 3 trial was conducted at 41 centers in 8 countries worldwide. Eligible patients were adults who had midgut neuroendocrine tumors that had metastasized or were locally advanced, that were inoperable, that were histologically confirmed and centrally verified, and that showed disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST], version 1.119 (link)) on either computed tomography (CT) or magnetic resonance imaging (MRI) over the course of a maximum period of 3 years during treatment with octreotide LAR (20 to 30 mg every 3 to 4 weeks for at least 12 weeks before randomization). Patients were required to have a Karnofsky performance-status score of at least 60 (on a scale from 0 to 100, with lower numbers indicating greater disability), a tumor with well-differentiated histologic features, and somatostatin receptors present on all target lesions (as confirmed by blinded, independent central review). Welldifferentiated histologic features were defined as a Ki67 index (the percentage of cells that are positive for Ki67 as determined by immunostaining of the primary tumor) of 20% or less; tumors were assessed as low-grade if they had a Ki67 index of 0 to 2%, intermediate-grade if they had a Ki67 index of 3 to 20%, or high-grade if they had a Ki67 index of greater than 20%, with a lower grade indicating a lower rate of proliferative activity. Target lesions were selected from CT or MRI, and the degree of expression of somatostatin receptors was determined on the basis of the lesion that had the highest uptake of radiotracer observed on planar somatostatin receptor scintigraphy within 24 weeks before randomization. All CT and MRI images were reviewed and evaluated for disease progression (according to RECIST criteria) and somatostatin receptor expression by independent central reviewers who were unaware of the treatment assignments.
Key exclusion criteria were a serum creatinine level of more than 150 μmol per liter (1.7 mg per deciliter) or a creatinine clearance of less than 50 ml per minute; a hemoglobin level of less than 8.0 g per deciliter; a white-cell count of less than 2000 per cubic millimeter; a platelet count of less than 75,000 per cubic millimeter; a total bilirubin level of more than 3 times the upper limit of the normal range; a serum albumin level of more than 3.0 g per deciliter, unless the prothrombin time value was within the normal range; treatment with more than 30 mg of octreotide LAR within 12 weeks before randomization; peptide receptor radionuclide therapy at any time before randomization; and any surgery, liver-directed transarterial therapy, or chemotherapy within 12 weeks before randomization.
Publication 2017
Adult Bilirubin Creatinine Cuboid Bone Disabled Persons Disease Progression Hemoglobin A Leukocyte Count Liver Neoplasms Neuroendocrine Tumors Octreotide Operative Surgical Procedures Patients Peptide Receptor Pharmacotherapy Platelet Counts, Blood Radioisotopes Radionuclide Imaging Serum Serum Albumin Somatostatin Receptor Therapeutics Times, Prothrombin X-Ray Computed Tomography
In this open-label, phase 3 trial, we randomly assigned patients, in a 1:1 ratio, to receive 177Lu-Dotatate plus best supportive care, consisting of octreotide LAR at a dose of 30 mg every 4 weeks for symptom control (177Lu-Dotatate group) or to receive high-dose octreotide LAR, at a dose of 60 mg every 4 weeks (control group). Randomization was performed with the use of a centralized permuted block (block size of 4) randomization scheme, with stratification according to the highest tumor uptake score on somatostatin receptor scintigraphy (grade 2, 3, or 4 on a scale ranging from 0 [no uptake by tumor] to 4 [very intense uptake by tumor] with higher grades indicating a higher level of expression of somatostatin receptors)12 (link) and according to the length of time that a patient had been receiving a constant dose of octreotide (≤6 months or >6 months).
In the 177Lu-Dotatate group, 7.4 GBq (200 mCi) of 177Lu-Dotatate was infused intravenously over a period of 30 minutes. Patients received four infusions every 8 weeks (cumulative radioactivity, 29.6 GBq [800 mCi]) unless unacceptable toxic effects occurred, centrally confirmed disease progression (according to RECIST) was present on imaging, the patient was unable or unwilling to adhere to trial procedures, the patient withdrew consent, or the patient died. For renal protection, an intravenous amino acid solution (Aminosyn II 10% [21.0 g of lysine and 20.4 g of arginine in 2 liters of solution] or VAMIN-18 [18 g of lysine and 22.6 g of arginine in 2 liters of solution]) was administered concomitantly for at least 4 hours, starting 30 minutes before infusion of the radiopharmaceutical. In the 177Lu-Dotatate group, patients continued to receive supportive care with octreotide LAR, which was administered intramuscularly at a dose of 30 mg approximately 24 hours after each infusion of 177Lu-Dotatate and then monthly after completion of all four treatments. In the control group, octreotide LAR at a dose of 60 mg was administered intramuscularly every 4 weeks. In both treatment groups, patients were allowed to receive subcutaneous rescue injections of octreotide in the event of hormonal symptoms (i.e., diarrhea or flushing) associated with their carcinoid syndrome.
Publication 2017
Amino Acids Aminosyn Arginine Diarrhea Disease Progression Kidney lutetium Lu 177 dotatate Lysine Malignant Carcinoid Syndrome Neoplasms Octreotide Patients Radioactivity Radionuclide Imaging Radiopharmaceuticals Somatostatin Receptor Subcutaneous Injections Vamin
The primary end point was progression-free survival, which was defined as the time from randomization to documented disease progression (as evaluated by independent central review by radiologists who were unaware of the treatment assignments) or death from any cause. Secondary end points included the objective response rate, overall survival (defined as the time from randomization to death from any cause), safety, and the side-effect profile. An objective tumor assessment on CT or MRI was performed every 12 weeks after the date of randomization in both treatment groups. The treatment was considered to have failed if a patient had progressive disease on imaging, according to central assessment with the use of RECIST criteria, and patients with treatment failure proceeded directly to the long-term follow-up phase. We calculated the response rate as the percentage of patients who had a response according to RECIST (sum of partial responses and complete responses). Definitions of all response categories are provided in the protocol.
Safety was assessed (at least every 2 to 12 weeks, depending on the phase of the trial [treatment phase or follow-up phase] and treatment group) on the basis of adverse events (which were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03), laboratory results (hematologic, chemical, and urologic), physical examinations, vital signs, electrocardiography, and Karnofsky performance status. Additional details are provided in the Supplementary Appendix, available at NEJM.org.
Publication 2017
Disease Progression Electrocardiography Neoplasms Patients Physical Examination Radiologist Safety Signs, Vital

Most recents protocols related to «Dotatate»

177Lu-DOTATATE was administered as an intravenous infusion of 7.4 GBq per treatment, planned with intended intervals of 6–10 weeks, based on multidisciplinary tumour board decisions. Treatment interval intention was mainly based on tumour aggressiveness in terms of primary tumour origin, tumour grade and proliferation of the tumour cells (Ki-67 index). Treatments were given with concomitant amino acid infusion.
Publication 2024
PET was performed on a Biograph mCT 40 scanner (siemens Healthcare, Erlangen, Germany). Patients were positioned supine with their arms outside of the region of interest. Images were obtained from the top of the skull to the upper thighs 64 ± 16.5 min (mean ± SD) after injection of 135 ± 25 (mean ± SD) MBq of 68Ga-DOTATATE (Canprobe; Toronto, ON, Canada). During uptake time, water-soluble oral contrast was given for bowel opacification on CT. Low-dose CT without intravenous contrast was used for attenuation correction as per standard departmental protocol. CT parameters were 120 kV; 3.0 mm slice width, 2.0 mm collimation; spiral pitch factor, 1.2. PET emission scan using time of flight with scatter correction was obtained, covering the identical transverse field of view. Image size: 2.6 pix size; slice 3.27; 5mm FWHM Gaussian Filter type. Overall, 5–9 bed positions were obtained as per patient height (2–5 min/bed position).
Publication 2024
Not available on PMC !
This study included consenting patients in a prospective observational study who underwent their first four cycles of 177 Lu-Dotatate treatment at our hospital. A total of 14 patients with NETs received 177 Lu-Dotatate treatment at our hospital between January 2022 and February 2024; however, one patient was excluded due to disagreement with the prospective observational study. Data analysis was limited to the first treatment cycle. The reason why we limited the data from cases that received the first treatment in four cycles was because there was one patient that the dose rate reduction rate significantly increased after subsequent cycles despite no significant changes in blood sampling data.
Publication 2024
Patients were evaluated by a multidisciplinary team to determine eligibility for 177 Lu-Dotatate treatment. The inclusion criteria were as follows: (1) pathologically confirmed NETs, (2) grade 2 or higher uptake (grade 2: equivalent to normal liver tissue; grade 3: greater than normal liver tissue, grade 4: higher than normal spleen or kidney tissue) by 111 In pentetreotide scintigraphy [16] , (3) platelet count ≥ 75,000 /μl, (4) creatinine clearance ≥ 40 ml/min, and (5) having no adverse events equal to or exceeding grade 3 classification based on the Common Terminology Criteria for Adverse Events version 5.0 [17] . Creatinine clearance was estimated using the Cockcroft-Gault equation in this study [18] , which was consistent with the NETTER-1 trial [7, 8] . The equation considers the patient's age in years, actual body weight in kg, and plasma creatinine level (Pcr). Final creatinine values for female subjects are reduced by multiplying the initial result by 0.85. The equation is presented below: After creatinine clearance estimation, patients received a 5HT 3 receptor antagonist 30 min before treatment, followed by 1000 ml of l-lysine/l-arginine hydrochloride 4 h later. Afterward, 7.4 GBq of 177 Lu-Dotatate is administered 30 min after initiating l-lysine/l-arginine hydrochloride administration and was completed within 30 min. Dose rate measurements at 1 m from the patient's body surface were performed immediately after 177 Lu-Dotatate treatment and 5.5-h post-administration using an ICS-311 device (ALOKA, Tokyo, Japan). Patients were asked to urinate 10 min before the start of 177 Lu-Dotatate administration, and
then were asked to refrain from urinating until dose rate measurements immediately post-administration. No restrictions or adjustments were made for urination at the time of 5.5-h measurement.
Publication 2024
Six to nine blood samples were collected at 0.5, 1, 2, 4, 8, 16, 24, 72 and 144 h post-injection in each patient. Blood was collected in the arm contralateral to that in which 177Lu-DOTATATE was injected. Blood samples were centrifuged at 1000xg for 10 min at ambient temperature. Radioactivity was measured in 1 ml aliquots of plasma using a WIZARD2™ 2480-0010 Gamma Counter (Perkin Elmer, MS, USA). A calibration curve with 177Lu-DOTATATE was established to normalize the data obtained with the gamma counter. Radioactivity-time data were expressed in MBq/L after correction for radioactive decay between the time of the sampling and the measurement according to the equation: C(t)corr=C(t)measured×e-Ln2T12,177Lu(tmeasured-t) where C(t)corr is 177Lu-Dotatate concentration at time t corrected for radioactive decay, C(t)measured is the 177Lu-Dotatate concentration measured at time tmeasured, T1/2,177Lu is the half-time disintegration of 177Lu and T0 is the time of 177Lu-Dotatate injection [29 (link)].
Publication 2024

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DOTATATE is a synthetic peptide used in the production of radiopharmaceuticals for diagnostic imaging. It serves as a precursor for the preparation of 68Ga-DOTATATE, which is used in positron emission tomography (PET) imaging of neuroendocrine tumors.
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More about "Dotatate"

Dotatate, also known as 68Ga-DOTA-TOC, is a radiopharmaceutical used for the imaging and treatment of neuroendocrine tumors.
It consists of a somatostatin analog (DOTA-TOC) labeled with the positron-emitting radionuclide gallium-68.
Dotatate binds to somatostatin receptors, which are overexpressed on the surface of many neuroendocrine tumors, allowing for the visualization and quantification of these tumors using positron emission tomography (PET) imaging.
Additionally, dotatate can be used for targeted radionuclide therapy of somatostatin receptor-positive tumors.
The use of dotatate has demonstrated high diagnostic accuracy and therapeutic efficacy in the management of neuroendocrine malignancies.
Researchers can optimize their dotatate studies using the AI-driven PubCompare.ai platform, which helps identify the most accurate and reproducible protocols from literature, preprints, and patents.
Synonyms and related terms for dotatate include somatostatin analog, DOTA-TOC, 68Ga-DOTA-TOC, and neuroendocrine tumor imaging agent.
Abbreviations such as PET, SPECT, and SSTR may also be relevant.
Key subtopics include molecular imaging, receptor-targeted therapy, and PET/CT or SPECT/CT imaging.
To further enrich the content, information from related technologies like SPSS Statistics, GraphPad Prism 7, Biograph mCT, CI-994, BD LSRFortessa analyzer, IC4224G, Kaluza Flow Cytometry Analysis v2.1 software, GraphPad Prism 5, and Prism 8 can be incorporated, as these tools may be used in dotatate research and analysis.
Remember to include a single human-like typo for a natural feel: 'PubComapre.ai'.