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

Primary Purpose

Cervical Cancer, HEENT Cancer, Renal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
124I-Iodo-Azomycin Galacto-Pyranoside
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring measurable disease, locally advanced disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Patients will receive 124IAZGP(124I-Iodo-Azomycin Galacto-Pyranoside).

Outcomes

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 with 124IAZGP

Secondary Outcome Measures

Full Information

First Posted
December 22, 2007
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00588276
Brief Title
Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
Official Title
Pilot Evaluation of 124I-Iodo-Azomycin Galacto-Pyranoside (*IAZGP) Positron Emission Tomography (PET) in the Imaging of Hypoxic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, HEENT Cancer, Renal Cancer, Uterine Cancer, CERVIX UTERI NOS, RECTUM
Keywords
measurable disease, locally advanced disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive 124IAZGP(124I-Iodo-Azomycin Galacto-Pyranoside).
Intervention Type
Radiation
Intervention Name(s)
124I-Iodo-Azomycin Galacto-Pyranoside
Intervention Description
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 Outcome Measure Information:
Title
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.
Title
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.
Title
To obtain further human dosimetry data with 124IAZGP
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko Schöder, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23731770
Citation
O'Donoghue JA, Guillem JG, Schoder H, Lee NY, Divgi CR, Ruby JA, Humm JL, Lee-Kong SA, Burnazi EM, Cai S, Carlin SD, Leibold T, Zanzonico PB, Ling CC. Pilot study of PET imaging of 124I-iodoazomycin galactopyranoside (IAZGP), a putative hypoxia imaging agent, in patients with colorectal cancer and head and neck cancer. EJNMMI Res. 2013 Jun 3;3(1):42. doi: 10.1186/2191-219X-3-42.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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