Active — Not RecruitingNot Applicable

Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

United States100 participantsStarted 2017-05-18

Plain-language summary

The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

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.

Inclusion Criteria: * Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging * No distant metastases, based on routine staging workup * Consent for blood collection for biomarker analysis * No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies * Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2 * Dispositioned to curative intent radiotherapy * For females of child-bearing age, a negative pregnancy test Exclusion Criteria: * Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity) * Pregnant or breast-feeding females * Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators) * History of claustrophobia * Contraindications to gadolinium contrast (e.g. kidney dysfunction)

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

Tumor growth velocity (TGV)

Timeframe: Baseline and up to 2-3 months after completion of radiation therapy

Change in TK

Timeframe: Baseline up to 2-3 months after radiation therapy

Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)

Timeframe: Baseline and up to 2-3 months after completion radiation treatment.

Trial details

NCT IDNCT03491176

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-31

View on ClinicalTrials.gov More Cutaneous Squamous Cell Carcinoma of the Head and Neck trials