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
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer HEENT Cancer Renal Cancer Uterine Cancer CERVIX UTERI NOS RECTUM||Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors|
|Study Start Date :||June 2005|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Patients will receive 124IAZGP(124I-Iodo-Azomycin Galacto-Pyranoside).
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588276
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Heiko Schöder, MD||Memorial Sloan Kettering Cancer Center|