Status:
ACTIVE_NOT_RECRUITING
Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Advanced Accelerator Applications
Conditions:
Neuroendocrine Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radi...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years old
- Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
- Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm).
Exclusion
- Participants with well-differentiated neuroendocrine tumors
- Participants who have undergone 68Ga-dotatate PET scan in the past
- Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04069299
Start Date
September 25 2019
End Date
January 1 2026
Last Update
December 5 2025
Active Locations (1)
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1
H Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612