AI and PET-MRI scans aim to personalize cancer radiation therapy
NCT ID NCT06256705
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes
ACTIVE_NOT_RECRUITINGNantes, 44000, France
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Médecine nucléaire - CHU Nantes
RECRUITINGNantes, 44000, France
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Médecine nucléaire et Biophysique - Beaujon
RECRUITINGClichy, 92110, France
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Pancréatologie et Oncologie Digestive - Beaujon
RECRUITINGClichy, 92110, France
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Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard
ACTIVE_NOT_RECRUITINGParis, 75018, France
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