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NCT06448208 Clinical Trial

Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:
Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06448208
Other study ID # 24-100
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2024
Est. completion date June 2026

Study information
Verified date June 2024
Source Memorial Sloan Kettering Cancer Center
Contact Lisa Bodei, MD, PhD
Phone 212-639-7373
Email bodeil@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

People with neuroendocrine cancer typically have imaging scans before and after treatment, including positron emission tomography (PET) scans. The scans are analyzed using a set of criteria that describes how the disease has responded to treatment. The purpose of this study is to establish new criteria for doctors to use when evaluating these PET scans. Researchers are testing whether these new criteria are useful for predicting whether a person's cancer gets better, gets worse, or stays the same. Researchers will also compare these new criteria to the current standard criteria for evaluating imaging scans.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• positron emission tomography (PET) scans
Before and after treatment.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center NeuroEndocrine Tumor Research Foundation (NETRF)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary validate the PRESCIENT criteria On this prospective validation cohort, the prognostic value of each criteria for the 1-year PFS will be assessed, using a Cox regression model (stratified on the site) and the area under the receiver operating curve (AUC) for time-dependent outcome using inverse probability of censoring weighting. 1 year
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