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Radioactive drug lutathera tested in teens with rare cancers

NCT ID NCT04711135

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a radioactive drug called Lutathera in teenagers aged 12 to 17 who have rare tumors of the digestive system or adrenal glands. The goal is to see if the drug is safe and how much radiation reaches organs. Eleven teens are taking part, and researchers are watching for side effects and measuring radiation doses.

What this could mean

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

Active substance
Lutathera (a radioactive drug given by IV)
What this could lead to
If it works, this could provide a new treatment option for teenagers with rare neuroendocrine tumors and related cancers that are hard to treat.
What could go wrong
This is a very small, early-phase study with only 11 participants, so results may not apply to all patients. The drug is radioactive and can cause side effects like kidney or bone marrow damage.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Feb 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 17 years

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.

Key Inclusion Criteria: 1. GEP-NET cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven, G1 or G2 (Ki-67 index =\< 20%), well differentiated GEP-NET. or PPGL cohort: presence of metastasized or locally advanced, inoperable (curative intent), histologically proven PPGL. 2. Patients from 12 to \< 18 years of age at the time of enrollment. 3. Expression of somatostatin receptors confirmed by a somatostatin receptor imaging (SRI) modality within 3 months prior to enrollment, with tumor uptake observed in the target lesions more or equal to the normal liver uptake. 4. Performance status as determined by Karnofsky score \>= 50 or Lansky Play-Performance Scale score \>= 50. 5. Parent's ability to understand and the willingness to sign a written informed consent document for adolescents as determined by local regulations. Adolescents will sign assent along with parental/legal guardian consent or will co-sign consent with parent/legal guardian in accordance with local regulation, prior to participation in the study. Key Exclusion Criteria: 1. Laboratory parameters: 1. Estimated creatinine clearance calculated by the Cockroft-Gault method \< 70 mL/min 2. Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<2x109/L; platelets \<75x109/L. 3. Total bilirubin \>3 x ULN for age. 4. Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. 2. Established or suspected pregnancy. 3. Breastfeeding female patients unless they accept to discontinue breastfeeding from the 1st dose until 3 months after the last administration of study drug. 4. Female patients of child-bearing potential, unless they are using highly effective methods of contraception during treatment and for 6 months after the last dose of Lutathera. 5. Sexually active male patients, unless they agree to remain abstinent or be willing to use effective methods of contraception. 6. Patients for whom in the opinion of the investigator other therapeutic options are considered more appropriate than the therapy offered in the study, based on patient and disease characteristics. 7. Current spontaneous urinary incontinence. 8. Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years. 9. Hypersensitivity to the study drug active substance or to any of the excipients. 10. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study. 11. Patient with known incompatibility to CT Scans with I.V. contrast due to allergic reaction or renal insufficiency. If such a patient can be imaged with MRI, then the patient would not be excluded. 12. Patients who received any investigational agent within the last 30 days.

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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.

Contacts and locations

Locations

  • Centre Léon Berard

    Lyon, France

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229-3039, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Gliwice, Poland

  • University College Hospital of London

    London, United Kingdom

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

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