Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors

Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06448208

Enrollment

Registered

2024-06-07

Start date

2024-06-03

Completion date

2027-06-01

Last updated

2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

PET scan, CT scan, 24-100

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.

Interventions

DIAGNOSTIC_TESTpositron emission tomography (PET) scans

Before and after treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
validate the PRESCIENT criteria	1 year	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLisa Bodei, MD, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026