NCT00588276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

7 years

First QC Date

December 22, 2007

Last Update Submit

December 23, 2015

Conditions

Cervical CancerHEENT CancerRenal CancerUterine CancerCERVIX UTERI NOSRECTUM

Keywords

measurable diseaselocally advanced disease

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

1

EXPERIMENTAL

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

Radiation: 124I-Iodo-Azomycin Galacto-Pyranoside

Interventions

124I-Iodo-Azomycin Galacto-PyranosideRADIATION

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 23731770DERIVED

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsKidney NeoplasmsUterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Heiko Schöder, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 8, 2008

Study Start

June 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)