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Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors

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ClinicalTrials.gov Identifier: NCT00588276
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE December 22, 2007
First Posted Date  ICMJE January 8, 2008
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE June 2005
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2009)
  • To describe imaging findings in human cancer with the new hypoxia tracer 124IAZGP and PET/CT [ Time Frame: at least once at approximately 6 hours and/or 24 hours after radiotracer administration. ]
  • To evaluate the biodistribution of 124IAZGP using serial PET imaging and to estimate blood radioactivity [ Time Frame: 5, 15, 30 and 60 minutes after 124IAZGP, and before and after each. A 5-mL volume of blood will be drawn at each sampling time point. ]
  • To obtain further human dosimetry data with 124IAZGP [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
To describe imaging of human cancer by 124IAZGP PET; and to evaluate the biodistribution of 124IAZGP using serial PET imaging and estimation of blood radioactivity. [ Time Frame: conclusion of study ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
Official Title  ICMJE Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
Brief Summary

The purpose of this study is to evaluate low oxygen areas called hypoxia within the tumor. These low oxygen areas are thought to be the reason why tumors are more resistant to radiation treatment. A tracer is an extremely small quantity of a substance. Tracer to which radioactivity has been attached may be used to "trace" events in the body. A tracer called iodo-azomycin galactopyranoside (or *IAZGP) appears to be able to detect low oxygen areas within tumor.

Radioactive iodine in this molecule can be detected by an imaging technique called a PET scan. This present study involves obtaining three scans using this new imaging technique. The goal of carrying out many scans is to determine which scan will best show any areas in your tumor that may have low levels of oxygen.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cervical Cancer
  • HEENT Cancer
  • Renal Cancer
  • Uterine Cancer
  • CERVIX UTERI NOS
  • RECTUM
Intervention  ICMJE Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside
You will receive the radioactive tracer through an injection in your vein. Blood (about 5 tablespoons in all) will be taken after the radioactive tracer has been given. Over the course of study day 1, bloods will be drawn 8 times and then 4 more times on study day 2. You will undergo three *IAZGP PET scans, one shortly after you receive the injection, one later the same day and one the following day. Each scan will take about an hour. This means you would be asked to come back 2 days in a row.
Study Arms  ICMJE Experimental: 1
Patients will receive 124IAZGP(124I-Iodo-Azomycin Galacto-Pyranoside).
Intervention: Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside
Publications * O'Donoghue JA, Guillem JG, Schöder H, Lee NY, Divgi CR, Ruby JA, Humm JL, Lee-Kong SA, Burnazi EM, Cai S, Carlin SD, Leibold T, Zanzonico PB, Ling CC. Pilot study of PET imaging of 124I-iodoazomycin galactopyranoside (IAZGP), a putative hypoxia imaging agent, in patients with colorectal cancer and head and neck cancer. EJNMMI Res. 2013 Jun 3;3(1):42. doi: 10.1186/2191-219X-3-42.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2007)
10
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have locally advanced cancer as determined by currently accepted diagnostic work-up, including CT/MR/US.
  • KPS >70%.
  • Patients must be > or equal to 18 years of age.

Exclusion Criteria:

  • Patients will be excluded from the study if they fulfill any of the following criteria:
  • Patients with abnormal baseline thyroid function tests, or any thyroid disorder including but not limited to hypothyroidism and thyroiditis. Patients with thyroid cancer who have had a thyroidectomy are not excluded.
  • Patients who are pregnant or lactating.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Patients who cannot tolerate being in the PET scanner for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00588276
Other Study ID Numbers  ICMJE 05-023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Heiko Schöder, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP