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Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG (mIBG)

Primary Purpose

Neuroendocrine Tumors, Heart Failure

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

no carrier added metaiodobenzylguanidine

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring Phase 1, no carrier added metaiodobenzylguanidine, radiation dosimetry

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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
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)
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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation dosimetry

Arm Description

no carrier added metaiodobenzylguanidine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01730417

First Posted

November 7, 2012

Last Updated

November 20, 2012

Sponsor

Bennett Chin

Collaborators

National Cancer Institute (NCI), Molecular Insights Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01730417

Brief Title

Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG

Acronym

mIBG

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bennett Chin

Collaborators

National Cancer Institute (NCI), Molecular Insights Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors, Heart Failure

Keywords

Phase 1, no carrier added metaiodobenzylguanidine, radiation dosimetry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation dosimetry

Arm Type

Experimental

Arm Description

no carrier added metaiodobenzylguanidine

Intervention Type

Drug

Intervention Name(s)

no carrier added metaiodobenzylguanidine

Other Intervention Name(s)

Ultratrace

Intervention Description

Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG

Primary Outcome Measure Information:

Title

Radiation dosimetry

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bennett B Chin, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24627436

Citation

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.

Results Reference

result

Learn more about this trial

Phase I Study of the Safety, Distribution, and Radiation Dosimetry of Ultratrace Iobenguane 123I-mIBG

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