Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: December 22, 2007
Last updated: June 1, 2012
Last verified: June 2012

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 Intervention
Cervical Cancer
HEENT Cancer
Renal Cancer
Uterine Cancer
Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • To obtain further human dosimetry data with 124IAZGP [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00588276

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Principal Investigator: Heiko Schöder, MD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT00588276     History of Changes
Other Study ID Numbers: 05-023
Study First Received: December 22, 2007
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
measurable disease
locally advanced disease processed this record on March 03, 2015