Targeted radiotherapy for malignant neuroendocrine tumors with MIBG

JRCT ID: jRCTs041190085

Registered date:22/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuroendocrine tumors
• Date of first enrollment: 27/11/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): All patients receive standard or high-dose I-131 MIBG.

Outcome(s)

• Primary Outcome: Assessment of anti-tumor effects with catecholamines in blood and urine

Secondary Outcome

1) Assessment of anti-tumor effects with RECIST and 123I-MIBG scintigraphy
2) Assessment of symptoms change
blood pressure seizure, bone pain
3) Assessment of prognosis (Overall survival; OS)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Seigo Kinuya