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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00038038
Other study ID # ID93-028
Secondary ID
Status Withdrawn
Phase N/A
First received May 24, 2002
Last updated July 31, 2012
Start date January 1994
Est. completion date June 2003

Study information

Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)?

2. If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors?

3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?


Description:

Hypoxic (low oxygen) cells have long been known to exist in animal tumors. It is also known that hypoxic cells are more difficult to eliminate with radiotherapy than tumor cells at normal levels of oxygen (normoxic cells). However, the extent to which hypoxic cells limit the curability of human tumors is uncertain. To determine if hypoxic cells exist in human tumors and how hypoxic cells might influence the efficacy of radiotherapy, this study involves direct measurements of oxygen levels in human tumors compared to the tumor uptake of the experimental drug, 18F-fluoromisonidazole (18F-FMISO), visualized with PET scanning. 18F-fluoromisonidazole has been used with PET imaging to tell the difference between growing tumors which have high and low oxygen content.

Before beginning radiotherapy, a PET scan (series of pictures, 20 min. scan) will be performed at 2 hours after an intravenous injection of a small amount of radioactive traces drug, 18F-fluoromisonidazole (18F-FMISO) to observe the active hypoxia tumors areas. Upon completion of the 18F-FMISO PET scan, direct oxygen measurements will be obtained by placing a small needle into the tumor under computer tomographic (CT) guidance. The PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy. The measurement obtained by 18F-FMISO PET scanning (non-invasive technique) and by direct needle measurements (invasive technique) will be correlated with the eventual treatment outcome for future use.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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%

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
18F-fluoromisonidazole
Small amount of radioactive traces drug given by intravenous injection prior to PET Scan
Procedure:
PET scan
Series of pictures using 20 minute scan performed 2 hours after an 18F-fluoromisonidazole injection

Locations

Country Name City State
United States University of Texas M. D. Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
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