search
Back to results

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

Primary Purpose

Pheochromocytoma, Paraganglioma, Carcinoid

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ultratrace iobenguane I 131
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pheochromocytoma focused on measuring radiopharmaceutical, radiation dosimetry, iodine, MIBG, iobenguane, Ultratrace, neuroendocrine tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. All patients in Arm P and Arm C must also meet each of the following inclusion criteria: 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 Exclusion Criteria: • 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    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
    blood and urine samples 24 hours post-dose
    blood and urine samples 48 hours post-dose
    blood and urine samples 120 hours post-dose
    continuous urine samples at intervals of 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 72-96 hours and 96-120 hours post-dose
    monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose

    Full Information

    First Posted
    June 17, 2006
    Last Updated
    October 7, 2011
    Sponsor
    Molecular Insight Pharmaceuticals, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00339131
    Brief Title
    ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid
    Official Title
    Phase 1 Study Evaluating the Safety, Distribution, Metabolism, and Radiation Dosimetry of ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma or Metastatic Carcinoid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Molecular Insight Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Iobenguane, which is also known as MIBG, has been used in many patients who have types of cancers caused by what are known as neuroendocrine tumors, such as pheochromocytoma, paraganglioma, and carcinoid. Iobenguane is absorbed by neuroendocrine tumor cells. The radioactive portion of the study drug, Ultratrace iobenguane, is a form of iodine called I 131. The I 131 is absorbed into the tumor with the iobenguane, and the radioactivity should kill the tumors. The type of iobenguane being studied is called Ultratrace because of the new way in which this form of iobenguane is made. This study is the first time in which Ultratrace iobenguane will be given to patients. The purpose of the study is to give a low dose of iobenguane just to find out if the drug is safe, to measure how long it takes the drug to be absorbed and passed out of the body, and to see how much radioactivity is absorbed by different types of tissues of the body.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pheochromocytoma, Paraganglioma, Carcinoid
    Keywords
    radiopharmaceutical, radiation dosimetry, iodine, MIBG, iobenguane, Ultratrace, neuroendocrine tumors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ultratrace iobenguane I 131
    Primary Outcome Measure Information:
    Title
    whole body imaging immediately post-dose
    Title
    whole body imaging 1 hour post-dose
    Title
    whole body imaging 3 hours post-dose
    Title
    whole body imaging 6 hours post-dose
    Title
    whole body imaging 24 hours post-dose
    Title
    whole body imaging 48 hours post-dose
    Title
    whole body imaging 120 hours post-dose
    Secondary Outcome Measure Information:
    Title
    blood and urine samples pre-dose
    Title
    blood and urine samples immediately post-dose
    Title
    blood and urine samples 1 hour post-dose
    Title
    blood and urine samples 3 hours post-dose
    Title
    blood and urine samples 6 hours post-dose
    Title
    blood and urine samples 24 hours post-dose
    Title
    blood and urine samples 48 hours post-dose
    Title
    blood and urine samples 120 hours post-dose
    Title
    continuous urine samples at intervals of 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 72-96 hours and 96-120 hours post-dose
    Title
    monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. All patients in Arm P and Arm C must also meet each of the following inclusion criteria: 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 Exclusion Criteria: • 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ralph E Coleman, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs