Targeted radiotherapy for malignant neuroendocrine tumors with MIBG

Phase 2

• Conditions: euroendocrine tumors; neuroendocrine tumors, I-131 MIBG therapy; D018358

• Registration Number: JPRN-jRCTs041190085
• Lead Sponsor: Seigo Kinuya

Brief Summary

Eighteen patients with malignant neuroendocrine tumors were treated with 131I-MIBG. Health insurance has covered 131I-MIBG treatment during the study. The study was terminated in the middle because all scheduled participants requested to discontinue participation. In addition, no participant asked for 131I-MIBG treatment at a higher dose. We evaluated data obtained up to study discontinuation. Catecholamines and their metabolites were considered decreased or stable. No serious adverse effects were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-22
• Study Completion: 2022-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1) Patients with histologically proven malignant neuroendocrine tumors
2) Patients with metastases, recurrent lesions or unresectable lesions
3) Positive I131-MIBg uptake
4) Performance Status (ECOG) 0or1, Patients with ADL adequate for treatment in an isolation room. Patients with limited ADL which can be compensated by the others under the approval of the ethical board.
5) Patients with written informed consent
(If a subject is minor who is 16 years of age or older) After informed consent for participating in the clinical study, a patient and a substitute have given their written consent.
(If the subject is under 16 years of age) After full informed consent to a substitute for participating in the clinical study and patient's informed assent, a substitute has given their written consent.
(Case in which it is difficult to obtain the consent of a subject alone who is not a minor under 16 years of age) After informed consent for participating in the clinical study, a substitute has given their written consent.

Exclusion Criteria

1)Preg nant female and feeding female 2)Patients with disturbed consciousness
3)An expected life expectancy of less than 1 month4)Limited bone marrow capacity
Hb<9.0, WBC count<3,000, platelet count <100,000
5)Renal disorder
GFR<30 ml/min/1.73 m2
6)Risks for the central nerve compression syndrome that might be caused by lesion edema during the treatment
7) In case that medical practice and radiation management is difficult in an isolation room, In case of uncontrolled symptoms that require emergent medical cares, In case that urine manag ement is difficult, In case that understanding and cooperation cannot be obtained from family members
8) When medical staffs determine that treatment cannot be properly carried out.

Study & Design

• Study Type: Interventional
• Study Design: Not specified