Clinical trial · Observational
Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors
Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| positron emission tomography (PET) scans | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- People With Neuroendocrine Tumors having a PET/CT or MRI
- description
- This is a non-interventional observational study of imaging.
- interventionNames
- Diagnostic Test: positron emission tomography (PET) scans
Primary outcomes (1)
- measure
- validate the PRESCIENT criteria
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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