Neuroendocrine TumorsPhase 1mIBGNCT01730417
Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG
A Phase 1 study testing no carrier added metaiodobenzylguanidine in people with Neuroendocrine Tumors and Heart Failure, run by Bennett Chin at 1 site in United States.
Trial summary
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Tumors, Heart Failure
- What is being tested?
- no carrier added metaiodobenzylguanidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2011
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal healthy volunteers with written informed consent who understand and are willing to comply with protocol requirements
- at least 21 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, a negative serum beta HCG pregnancy test within 24 hours prior to receiving iobenguane I 123
- 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
- No existing predisposition to administration of thyroid blocking potassium iodide
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
- abnormal screening laboratory studies (serum creatinine, SPOT, SGPT, total bilirubin as defined by standard laboratory reference ranges)
- those who have received an investigational compound and/or medical device within 30 days of entering this study
- pre-existing medical condition or circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study, (e.g. cancer, heart disease, or other medical conditions which potentially alter normal biodistribution)
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- is determined by the investigator that the patient is clinically unsuitable for the study
- are taking medication which inhibits uptake of iobenguane I 123 within 2 weeks of enrollment, or tricyclic antidepressants or related drugs within 6 weeks of enrollment. Categories of medications include sympathomimetics, antihypertensives and cardiovascular agents, opioids, antipsychotics, tricyclic antidepressants, and medications as previously published
- have participated in a clinical trial with an investigational drug in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers.
Read the detailed description
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown to be useful for the detection and staging of neuroendocrine tumors in adults and children and imaging neuronal activity in the heart. The innovation in this proposal is through the use of patented solid phase technology to produce a proven diagnostic agent at extremely high specific activity to increase sensitivity and specificity and lower radiation exposure to normal organs without the pharmacologically active cold carrier compound. The FDA considers iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct drugs requiring distinct regulatory applications.
To meet the required quality standards for the chemistry, manufacturing and controls component of an IND application, GMP quality polymer drug precursor is used to generate the Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed final drug formulation to demonstrate the final drug does not interfere with tests used to define the identity, purity, and strength of the agent. The drug product was verified for apyrogenicity and sterility before human testing. The IND application was written and submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material, and will conduct human testing of the radioactive drug substance for safety and superiority compared to conventional iobenguane I 123 in normal healthy volunteers.
- Conditions
- Neuroendocrine Tumors, Heart Failure
- Being tested
- no carrier added metaiodobenzylguanidine
- Keywords
- Phase 1, no carrier added metaiodobenzylguanidine, radiation dosimetry
- Medical subject headings
- Neuroendocrine Tumors, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no carrier added metaiodobenzylguanidineDrug
Also called Ultratrace
Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
| Study group | Role | What they receive |
|---|---|---|
| Radiation dosimetry | Experimental | no carrier added metaiodobenzylguanidine Receives: Drug: no carrier added metaiodobenzylguanidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dosimetry
Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bennett Chin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Molecular Insights Pharmaceuticals
- Responsible party
- Sponsor-investigator, Bennett Chin, Duke University
- Investigators
- Bennett B Chin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730417
- Sponsor's protocol ID
- Pro00019124 (MIP-CA130394-01)
- Other IDs
- 5R44CA130394-03
- Acronym
- mIBG
- Status last verified
- Nov 2012
- First submitted
- 7 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765-71. doi: 10.2967/jnumed.113.124057. Epub 2014 Mar 13.
PubMed 24627436
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG-Nanodosing: the Path to Higher Sensitivity and Lower Toxicity Radiopharmaceuticals
- ClinicalTrials.gov ID
- NCT01730417
- Acronym / sponsor ID
- mIBG / Pro00019124 (MIP-CA130394-01)
- Conditions
- Neuroendocrine Tumors, Heart Failure
- Keywords
- Phase 1, no carrier added metaiodobenzylguanidine, radiation dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bennett ChinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Molecular Insights Pharmaceuticals
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Nov 2012 (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 goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers.
Detailed description
The goal of this proposal is to produce and test high specific activity Ultratrace iobenguane I 123 in normal human volunteers. The low specific activity iobenguane I 123 has been shown to be useful for the detection and staging of neuroendocrine tumors in adults and children and imaging neuronal activity in the heart. The innovation in this proposal is through the use of patented solid phase technology to produce a proven diagnostic agent at extremely high specific activity to increase sensitivity and specificity and lower radiation exposure to normal organs without the pharmacologically active cold carrier compound. The FDA considers iobenguane labeled with two different isotopes of iodine [I-131 and I-123] as two distinct drugs requiring distinct regulatory applications.
To meet the required quality standards for the chemistry, manufacturing and controls component of an IND application, GMP quality polymer drug precursor is used to generate the Ultratrace diagnostic iodine-123 agent. Analytical methods were validated with the proposed final drug formulation to demonstrate the final drug does not interfere with tests used to define the identity, purity, and strength of the agent. The drug product was verified for apyrogenicity and sterility before human testing. The IND application was written and submitted to the FDA and the Duke Medical Center IRB. MIP produces clinical trial material, and will conduct human testing of the radioactive drug substance for safety and superiority compared to conventional iobenguane I 123 in normal healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation dosimetry | Experimental | Drug: no carrier added metaiodobenzylguanidineno carrier added metaiodobenzylguanidine |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- normal healthy volunteers with written informed consent who understand and are willing to comply with protocol requirements
- at least 21 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, a negative serum beta HCG pregnancy test within 24 hours prior to receiving iobenguane I 123
- 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
Key exclusion criteria (9 listed)
- 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
- abnormal screening laboratory studies (serum creatinine, SPOT, SGPT, total bilirubin as defined by standard laboratory reference ranges)
- those who have received an investigational compound and/or medical device within 30 days of entering this study
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 |
|---|---|---|
| no carrier added metaiodobenzylguanidineAlso: UltratraceSequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG | Drug | Radiation dosimetry |
Primary outcome
Radiation dosimetry
Time frame: 2 weeks
Radiation dosimetry was measured by imaging at several time points. Blood and urine samples were also collected to correlate with imaging parameters. Side effects were also assessed after drug administration.
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 21 Nov 2012.
- Results publication: PubMed 24627436Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765-71. doi: 10.2967/jnumed.113.124057. Epub 2014 Mar 13.
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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.
Bennett B Chin, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing no carrier added metaiodobenzylguanidine in people with Neuroendocrine Tumors and Heart Failure, run by Bennett Chin at 1 site in United States.
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 6 inclusion and 9 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Radiation dosimetry (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730417, which also lists 1 linked publication.
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 21 Nov 2012.