NCT00588276|CompletedPhase 1
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Sponsor study identifier
interventional
15
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 22, 2007
Actual (reported)January 8, 2008
Actual (reported)June 2012
Actual (reported)June 2012
Actual (reported)To describe imaging findings in human cancer with the new hypoxia tracer 124IAZGP and PET/CT
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
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
2 years
Patients will receive 124IAZGP(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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
O'Donoghue JA, Guillem JG, Schoder 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.
Heiko Schöder, MD
Memorial Sloan Kettering Cancer Center
15 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2007
First Posted
January 8, 2008
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Contact the study team to confirm eligibility.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
December 24, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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