Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
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|ClinicalTrials.gov Identifier: NCT04069299|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment|
|Neuroendocrine Carcinoma||Drug: 68Ga-DOTATATE Diagnostic Test: Positron Emission Tomography (PET) Scan|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2021|
Participants receiving PET scan
Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection
Other Name: NETspot
Diagnostic Test: Positron Emission Tomography (PET) Scan
PET scan is an imaging test using radioactive tracers.
- Percentage of Participants with Uniformly Positive 68Ga-dotatate PET [ Time Frame: Up to 10 months ]Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
- Percentage of Participants with No Uptake to Very High Uptake on PET [ Time Frame: Up to 10 months ]Percentage of Participants with no uptake, heterogeneous uptake (tumors showing substantial differences in Somatostatin receptor [SSTR] uptake), low uptake (max SUV≤ liver), moderate uptake (liver<max SUV ≤2x liver, high uptake (max SUV > 2x liver), very high uptake (max SUV≥ kidney or spleen). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069299
|United States, Florida|
|H Lee Moffitt Cancer & Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Taymeyah Al-Toubah 813-745-6454 Taymeyah.Al-Toubah@moffitt.org|
|Principal Investigator: Jonathan Strosberg, MD|
|Principal Investigator:||Jonathan Strosberg, MD||H Lee Moffitt Cancer & Research Institute|