Establishing new criteria for PET scans in neuroendocrine tumors
Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
This study is testing new guidelines for reading PET scans in patients with neuroendocrine tumors to see if they can better predict how well treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06448208 on ClinicalTrials.gov |
What this trial studies
This study aims to define new response criteria for evaluating PET scans in patients with neuroendocrine tumors. By analyzing how these tumors respond to treatment using these new criteria, researchers hope to improve the accuracy of predicting disease progression. The study will compare the effectiveness of these new criteria against the current standard methods used in clinical practice. Participants will undergo PET scans to assess their tumor response, contributing valuable data to enhance treatment evaluation.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed, metastatic or inoperable well-differentiated neuroendocrine tumors that overexpress somatostatin receptors.
Not a fit: Patients with neuroendocrine carcinoma or those with somatostatin receptor negative lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of treatment responses in patients with neuroendocrine tumors.
How similar studies have performed: While the approach of defining new criteria for imaging response is common, the specific focus on neuroendocrine tumors and PET scans may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Subjects affected by histologically proven, somatostatin-receptor positive, metastatic or inoperable well-differentiated G1, G2 or G3 neuroendocrine tumors (NETs) candidate to receive PRRT with 177Lu-DOTATATE per standard of care. Inclusion Criteria: 1. Histologically proven or cytologically confirmed, metastatic or inoperable NETs 2. Measurable disease as defined by RECIST 1.1. 3. Overexpression of somatostatin receptors of the target lesions at somatostatin receptor imaging (68Ga-DOTATATE or 64Cu-DOTATATE PET/CT) with SUV of lesions greater than normal liver at least in 1 metastasis. Exclusion Criteria: 1. Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN). 2. Presence of somatostatin receptor negative lesions.
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Bodei, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Lisa Bodei, MD, PhD
- Email: bodeil@mskcc.org
- Phone: 212-639-7373
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.