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AI and PET-MRI scans aim to personalize cancer radiation therapy

NCT ID NCT06256705

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is looking at people with a rare type of digestive system cancer called GEP-NET who are receiving a targeted radiation therapy (PRRT). Researchers will use special PET-MRI scans and artificial intelligence to find patterns that predict how well the treatment works. The goal is to better select patients who will benefit most from PRRT. About 80 participants will be followed for 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
68Ga-DOTATOC PET-MRI imaging
What this could lead to
If successful, this could lead to better ways to predict which patients will benefit most from targeted radiation therapy for GEP-NET tumors.
What could go wrong
This is an observational imaging study, not a treatment trial. It will not directly test a new therapy, and results may not change current practice for years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * According the MDT decision to refer to PRRT 1. Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin 2. Metastastic and progressive according RECIST 1.1 criteria 3. At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging 4. SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake) 5. The majority of the lesions and all RECIST 1.1 selected target lesion have to be SSTR+. * Karnofsky performance status scale ≥ 60 * Live expectancy \>6 months * Patients ≥ 18 years of age Exclusion Criteria: * Known pregnancy or breastfeeding women * Known hypersensitivity to 177Lu, octreotate, DOTA, 68Ga, Edotreotide, * Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution (AAS) given concomitantly to the 177Lu-DOTATATE infusion. * Contraindication to MRI and technical impossibility of MRI * Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive * Other systemic antitumor treatment (non-radioactive, excluding somatostatin analogues) not interrupted for at least 4 weeks * Mixed Neuroendocrine-Non-endocrine Neoplasms (MiNEN) * Neuroendocrine carcinoma * Uncontrolled brain metastasis for at least 3 months * NYHA 3 or 4 heart failure * Inability to discontinue delayed-acting somatostatin analogues at least 28 days prior the PRRT or rapid-acting somatostatin analogues at least 24 hours prior the PRRT * Non-adequate bone marrow, liver and renal function within 1 month prior the PRRT as assessed by the following laboratory tests: * Platelet count \< 75,000/mm3 * Haemoglobin ≤ 8,0 g/dL * Total bilirubin \> 3 ULN * Neutrophils \< 1000/mm3 * Prothrombin time \< 70% unless albumin \> 30g/L * Albumin \<30g/L unless prothrombin time \> 70 % * Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2 * Prior peptide receptor radionuclide therapy (PRRT) * Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years * Patient refusal to give written informed consent * Subject deprived of freedom, subject under a legal protective measure * No affiliation to a social security regimen or CMU * Patient under State Medical Aid

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes

    ACTIVE_NOT_RECRUITING

    Nantes, 44000, France

  • Médecine nucléaire - CHU Nantes

    RECRUITING

    Nantes, 44000, France

  • Médecine nucléaire et Biophysique - Beaujon

    RECRUITING

    Clichy, 92110, France

  • Pancréatologie et Oncologie Digestive - Beaujon

    RECRUITING

    Clichy, 92110, France

  • Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard

    ACTIVE_NOT_RECRUITING

    Paris, 75018, France

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