Neuroendocrine TumorsNCT06448208
Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- positron emission tomography (PET) scans
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
- Presence of somatostatin receptor negative lesions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
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
- Neuroendocrine Tumors
- Being tested
- positron emission tomography (PET) scans
- Keywords
- PET scan, CT scan, 24-100
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomography (PET) scansDiagnostic test
Before and after treatment.
| Study group | Role | What they receive |
|---|---|---|
| People With Neuroendocrine Tumors having a PET/CT or MRI | This is a non-interventional observational study of imaging. Receives: Diagnostic Test: positron emission tomography (PET) scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start3 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroEndocrine Tumor Research Foundation (NETRF)
- Responsible party
- Sponsor
- Investigators
- Lisa Bodei, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448208
- Sponsor's protocol ID
- 24-100
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of PET REsponSe CrItEria for Neuroendocrine Tumors (PRESCIENT)
- ClinicalTrials.gov ID
- NCT06448208
- Acronym / sponsor ID
- 24-100
- Conditions
- Neuroendocrine Tumors
- Keywords
- PET scan, CT scan, 24-100
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- NeuroEndocrine Tumor Research Foundation (NETRF)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People With Neuroendocrine Tumors having a PET/CT or MRI | – | Diagnostic Test: positron emission tomography (PET) scansThis is a non-interventional observational study of imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
- Presence of somatostatin receptor negative lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positron emission tomography (PET) scansBefore and after treatment. | Diagnostic test | People With Neuroendocrine Tumors having a PET/CT or MRI |
Primary outcome
validate the PRESCIENT criteria
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Bodei, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validate the PRESCIENT criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.