PheochromocytomaPhase 1NCT00339131
ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid
A Phase 1 study testing Ultratrace iobenguane I 131 in people with Pheochromocytoma and Paraganglioma, run by Molecular Insight Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Paraganglioma, Carcinoid
- What is being tested?
- Ultratrace iobenguane I 131
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- • 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
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Pheochromocytoma, Paraganglioma, Carcinoid
- Being tested
- Ultratrace iobenguane I 131
- Keywords
- radiopharmaceutical, radiation dosimetry, iodine, MIBG, iobenguane, Ultratrace, neuroendocrine tumors
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Carcinoid Tumor, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultratrace iobenguane I 131Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph E Coleman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339131
- Sponsor's protocol ID
- MIP-IB11
- Status last verified
- Oct 2011
- First submitted
- 17 Jun 2006
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00339131
- Acronym / sponsor ID
- MIP-IB11
- Conditions
- Pheochromocytoma, Paraganglioma, Carcinoid
- Keywords
- radiopharmaceutical, radiation dosimetry, iodine, MIBG, iobenguane, Ultratrace, neuroendocrine tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients will enter one of two study arms depending on their type of neuroendocrine tumor.
- 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.
- Have a histopathological diagnosis of carcinoid, or by plasma chromogranin A (CgA) and 24-hour urine test for 5-hydroxyindole-acetic-acid (5HIAA)
Key exclusion criteria (11 listed)
- • Females who are nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultratrace iobenguane I 131 | Drug | – |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph E Coleman, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultratrace iobenguane I 131 in people with Pheochromocytoma and Paraganglioma, run by Molecular Insight Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whole body imaging immediately post-dose. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.