ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid

NCT00339131 | Completed Phase 1

• 1 other identifier: MIP-IB11
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131 that has radioactivity, to measure how long it takes for the drug to be absorbed and passed out of the body, and to measure how much radioactivity is absorbed into different tissues of the body.

Conditions

Pheochromocytoma; Paraganglioma; Carcinoid

Keywords

radiopharmaceutical; radiation dosimetry; iodine; MIBG; iobenguane; Ultratrace; neuroendocrine tumors

Outcome Measures

Primary Outcomes (7)

• whole body imaging immediately post-dose

• whole body imaging 1 hour post-dose

• whole body imaging 3 hours post-dose

• whole body imaging 6 hours post-dose

• whole body imaging 24 hours post-dose

• whole body imaging 48 hours post-dose

• whole body imaging 120 hours post-dose

Secondary Outcomes (10)

• blood and urine samples pre-dose

• blood and urine samples immediately post-dose

• blood and urine samples 1 hour post-dose

• blood and urine samples 3 hours post-dose

• blood and urine samples 6 hours post-dose

Interventions

Ultratrace iobenguane I 131 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will enter one of two study arms depending on their type of neuroendocrine tumor.
• Arm P patients must:
• Have a biochemical or histopathological diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma (biochemical diagnosis includes plasma-free metanephrines and 24-hour urine test for catecholamines/metanephrines)
• Disease is metastatic or has recurred following surgery
• Have a CT scan performed (for later measurement of disease volume by the core lab) within 90 days of the administration of study drug without any interventions between CT and iobenguane I 131 imaging.
• Arm C patients must:
• Have a histopathological diagnosis of carcinoid, or by plasma chromogranin A (CgA) and 24-hour urine test for 5-hydroxyindole-acetic-acid (5HIAA)
• Disease is metastatic or has recurred following surgery
• Have a CT scan performed (for the later measurement of disease volume by the core lab) within 90 days of the administration of study drug without any interventions between CT and iobenguane I 131 imaging.
• Provide written informed consent and are willing to comply with protocol requirements
• Are at least 18 years of age
• If female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
• If female of childbearing potential, has a negative serum HCG pregnancy test within 24 hours prior to receiving iobenguane I 131
• If female of childbearing potential, agrees to use an acceptable form of birth control, defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant, throughout the study period

You may not qualify if:

• Females who are nursing
• Documented history of significant allergy that required medical intervention to shellfish, X-ray contrast media , iodine/iodides, or iobenguane
• Administered a radioisotope within 5 effective half-lives of that radioisotope prior to study enrollment
• Karnofsky performance status is \< 60
• Serum creatinine \> 2.0 mg/dL
• Total bilirubin \> 1.5 times the upper limit of normal
• AST/SGOT or ALT/SGPT \> 3 times the upper limit of normal
• Has received an investigational compound and/or medical device within 30 days before admission into this study
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
• Is determined by the Investigator that the patient is clinically unsuitable for the study
• Has received a medication which inhibits uptake of iobenguane I 131 within 2 weeks prior to the administration of study drug. Patients must not have taken tricyclic antidepressants or related drugs within 6 weeks prior to enrollment.

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma; Carcinoid Tumor; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Ralph E Coleman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2006
• First Posted: June 20, 2006
• Study Start: June 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 12, 2011

Record last verified: 2011-10