Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00037869
Eligibility Criteria:
Inclusion Criteria:
* Age: 2 years of age and older
* Sex: male or female; female patients with child bearing potential must have a negative serum HCG pregnancy test within 72 hours prior to treatment;
* Diagnostic criteria- Patients must meet all of the following:
1. Histologically documented neuroendocrine tumor.
2. Labeled MIBG concentration in the tumor site(s) on diagnostic scan.
3. good to excellent performance status.
* A patient for whom written voluntary informed consent has been obtained prior to study and participation.
* Patients can have had prior chemotherapy, as long as hematological parameters meet specifications.
* Please refer to Appendix D Drugs and Other Interactions for list of medications patient needs to cease 2 weeks prior to therapy. Patient should check with primary physician after therapy about resuming these medications.
* Patients with treatment refractory or relapsed advanced or disease not amendable to significant response (\>25% to available chemotherapy) or metastatic disease not amenable to standard therapy.
Exclusion Criteria:
* Patients with inadequate hematopoietic bone marrow function: ANC\<1000 cells/mm3, or platelets\<75k cells/mm3 or hemoglobin\<10g/dL.
* Patients with impaired renal function: creatinine\>1.5mg/dL.
* Patients with impaired hepatic function: AST or ALT \> 3.0 X upper limit of normal or total bilirubin \> 2.0 mg/dL.
* Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
* Female patients who are breast-feeding.
* Children less than 2 years of age.
* Patients with previous total body irradiation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00037869
Study Brief:
Protocol Section:
NCT00037869