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Completed

NCT Number: NCT00588276

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

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.

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Key information

Conditions

Cervical Cancer CERVIX UTERI NOS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HEENT Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site RECTUM Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

124I-Iodo-Azomycin Galacto-Pyranoside

Radiation

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.

Primary outcomes

  1. 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.

  2. 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.

  3. To obtain further human dosimetry data with 124IAZGP

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jan 8, 2008
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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