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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588276
• Other study ID #: 05-023
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2007
• Last updated: December 23, 2015
• Start date: June 2005
• Est. completion date: June 2012

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Cervical Cancer
• CERVIX UTERI NOS
• HEENT Cancer
• Kidney Neoplasms
• RECTUM
• Renal Cancer
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	To obtain further human dosimetry data with 124IAZGP		2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center