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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00442533
Eligibility Criteria:
Inclusion Criteria:
* Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.
* Patients must have evidence of residual multifocal active tumor.
* All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.
* All patients must have a Karnofsky performance status of at least 60.
* Patients must be greater than 18 years of age.
* Patients must have measurable and/or followable disease based on either clinical or radiologic exam.
* Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.
* An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound).
* If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.
Exclusion Criteria:
* Karnofsky performance status of 50 or less.
* Patients who are unable to give informed consent.
* Patients under 18 years of age. There will be no upper age discrimination.
* Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.
* Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00442533
Study Brief:
Protocol Section:
NCT00442533