Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00588276|
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : December 24, 2015
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
|Actual Primary Completion Date :||June 2012|
|Actual 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|First Posted:||January 8, 2008 Key Record Dates|
|Last Update Posted:||December 24, 2015|
|Last Verified:||December 2015|
locally advanced disease
Genital Neoplasms, Female
Neoplasms by Site