Neuroendocrine Carcinoma
Conditions
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 radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
Interventions
DRUG68Ga-DOTATATE
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
DIAGNOSTIC_TESTPositron Emission Tomography (PET) Scan
PET scan is an imaging test using radioactive tracers.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Advanced Accelerator Applications
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Uniformly Positive 68Ga-dotatate PET | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with No Uptake to Very High Uptake on PET | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Strosberg, MD
H Lee Moffitt Cancer & Research Institute
Outcome results
None listed