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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer, HEENT Cancer, Renal Cancer, Uterine Cancer, CERVIX UTERI NOS, RECTUM

Intervention / Treatment
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* Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will receive 124IAZGP(124I-Iodo-Azomycin Galacto-Pyranoside). | Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| To obtain further human dosimetry data with 124IAZGP |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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measurable disease, locally advanced disease