Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588276
First received: December 22, 2007
Last updated: June 1, 2012
Last verified: June 2012
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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 |
| 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.
|
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
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Heiko Schöder, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov 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 |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Genital Neoplasms, Female Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on October 17, 2012
