CompletedPhase 2

EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer

United States8 participantsStarted 2002-08

Plain-language summary

RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Clinically detectable disease by physical examination or radiographic studies * Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL Renal * Creatinine no greater than 1.8 mg/dL Other * No allergy to IV contrast dye * No prior grade III or IV peripheral neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 week after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Concurrent radiotherapy allowed Surgery * See Disease Characteristics

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual

Timeframe: One Year

Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

Timeframe: One year

Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual

Timeframe: One Year

Spatial coordination as measured by EF5 binding at completion of accrual

Timeframe: One Year

Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual

Timeframe: One year

Trial details

NCT IDNCT00049140

SponsorDavid M. Brizel, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-10

View on ClinicalTrials.gov More Head and Neck Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual

Timeframe: One Year

Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

Timeframe: One year

Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual

Timeframe: One Year

Spatial coordination as measured by EF5 binding at completion of accrual

Timeframe: One Year

Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual

Timeframe: One year