Evaluating somatostatin receptor expression in neuroendocrine carcinoma using PET scans
Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
H. Lee Moffitt Cancer Center and Research Institute · NCT04069299
This study is testing how well a special type of PET scan can show the presence of certain receptors in patients with a specific type of cancer to see if it could help guide future treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute (other) |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04069299 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the extent and degree of somatostatin receptor expression in patients with poorly differentiated neuroendocrine carcinomas of the gastrointestinal tract. By utilizing 68Ga-dotatate PET scans, the study seeks to gather data that may inform the potential use of peptide receptor radiotherapy (PRRT) as a treatment option in the future. Currently, the efficacy of radiolabeled somatostatin analogs in this specific cancer type is not well understood, making this investigation crucial for future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histologically confirmed diagnosis of poorly differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract.
Not a fit: Patients with well-differentiated neuroendocrine tumors or those who have previously undergone a 68Ga-dotatate PET scan may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could pave the way for new treatment options for patients with poorly differentiated neuroendocrine carcinomas.
How similar studies have performed: While the specific application of radiolabeled somatostatin analogs in poorly differentiated neuroendocrine carcinomas is novel, similar approaches have shown promise in other types of neuroendocrine tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tampa, Florida
- H Lee Moffitt Cancer & Research Institute — Tampa, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan Strosberg, MD — H Lee Moffitt Cancer & Research Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Carcinoma