Targeted radiopharmaceutical radiotherapy for relapsed or refractory neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study gives fractionated doses of [211At]MABG radiotherapy to patients with relapsed or refractory neuroblastoma who have MIBG-avid disease. The trial focuses on safety, tolerability, and early signals of activity in a controlled dosing schedule. Eligible participants have high-risk disease, measurable MIBG-avid lesions, adequate organ function, and a reasonable performance status. Prior therapies must meet specific washout criteria, and recent radiotherapies or stem cell transplants influence eligibility. Conducted at West China Hospital with Sichuan University as lead sponsor, the study uses a targeted radiopharmaceutical approach tailored to individual disease biology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.
2. All measurable soft tissue lesions must be MIBG-avid.
3. Age ≥ 1 year at enrollment.
4. Lansky performance status ≥ 50%.
5. Adequate organ function and hematologic parameters.

Exclusion Criteria:

1. Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy.
2. Treatment with \[¹³¹I\]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.
3. Autologous stem cell transplant \<12 weeks, or Allogeneic stem cell transplant \<4 months (patients \>4 months post-transplant must be free of active GVHD).
4. Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or \>50% of bone marrow area) within 12 weeks prior to the first study dose.
5. Renal Insufficiency.
6. Active Infections.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Rong TIAN, MD — West China Hospital
• Study coordinator: Rong TIAN, MD
• Email: rongtiannuclear@126.com
• Phone: +86 189 8060 1586

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.