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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588276

Purpose

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 CERVIX UTERI NOS Rectum	Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside

MedlinePlus related topics: Cancer Kidney Cancer Nuclear Scans Radiation Therapy Uterine Cancer

Drug Information available for: Galactose

U.S. FDA Resources

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

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. To evaluate the biodistribution of 124IAZGP using serial PET imaging and to estimate blood radioactivity. To obtain further human dosimetry data with124IAZGP. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588276

Contacts

Contact: Heiko Schöder, MD		schoderh@mskcc.org
Contact: Nancy Lee, MD	212-639-3341	leen2@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Heiko Schöder, MD schoderh@mskcc.org
Contact: Nancy Lee, MD 212-639-3341 leen2@mskcc.org
Principal Investigator: Heiko Schoder, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Heiko Schöder, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Heiko Schöder, MD )
Study ID Numbers:	05-023
Study First Received:	December 22, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00588276 History of Changes
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

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Genital Diseases, Female

Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Uterine Neoplasms
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Genital Diseases, Female
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Uterine Neoplasms
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009