Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors
Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
1 other identifier
observational
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedStudy Start
First participant enrolled
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedMarch 9, 2026
March 1, 2026
2 years
June 3, 2024
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
People With Neuroendocrine Tumors having a PET/CT or MRI
This is a non-interventional observational study of imaging.
Interventions
Before and after treatment.
Eligibility Criteria
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).
You may qualify if:
- Histologically proven or cytologically confirmed, metastatic or inoperable NETs
- Measurable disease as defined by RECIST 1.1.
- 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.
You may not qualify if:
- Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
- Presence of somatostatin receptor negative lesions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Bodei, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 7, 2024
Study Start
June 3, 2024
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.