NCT00038038

Brief Summary

The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent:

  1. 1.Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?
  2. 2.If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?
  3. 3.Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 1994

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 1994

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

9.4 years

First QC Date

May 24, 2002

Last Update Submit

July 31, 2012

Conditions

Squamous Cell CarcinomaHead and Neck NeoplasmsMetastases, Neoplasm

Keywords

Squamous cell carcinoma of head and neck

Outcome Measures

Primary Outcomes (1)

  • Direct Oxygen Measurements

    PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.

Study Arms (1)

PET + 18F-fluoromisonidazole

EXPERIMENTAL
Drug: 18F-fluoromisonidazoleProcedure: PET scan

Interventions

18F-fluoromisonidazoleDRUG

Small amount of radioactive traces drug given by intravenous injection prior to PET Scan

Also known as: 18F-FMISO
PET + 18F-fluoromisonidazole
PET scanPROCEDURE

Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection

PET + 18F-fluoromisonidazole

Eligibility Criteria

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

You may qualify if:

  • Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm
  • Karnofsky performance status greater or equal to 60%

You may not qualify if:

  • No prior irradiation or surgery to head/neck area
  • No prior chemotherapy within 1 month of participation and have recovered from associated related effects
  • Not pregnant
  • Any intercurrent medical or physiologic disorder which would prevent informed consent
  • Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy
  • Patients with PT or PTT over 1.5 times normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Squamous CellHead and Neck NeoplasmsNeoplasm MetastasisSquamous Cell Carcinoma of Head and Neck

Interventions

fluoromisonidazoleMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Donald A Podoloff, M.D.

    UT MD Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2002

First Posted

May 27, 2002

Study Start

January 1, 1994

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)