Clinical trial NCT03491176: Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer
Official title: Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma of the Head and Neck
Healthy Subject
Head and Neck Cancer
Keywords: Head and Neck Cancer
Magnetic resonance imaging
MRI
Biomarker testing
Blood draws
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI).

SECONDARY OBJECTIVES:

I. To assess functional imaging kinetics as a marker of tumor locoregional control.

II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials.

OUTLINE:

Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.

After completion of study, patients are followed up weekly.

Eligibility criteria: 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)

Primary outcomes:
measure: Tumor growth velocity (TGV)
timeFrame: Baseline and up to 2-3 months after completion of radiation therapy
measure: Change in TK
timeFrame: Baseline up to 2-3 months after radiation therapy
measure: 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.
Secondary outcomes:
measure: Locoregional control
timeFrame: From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Clifton D Fuller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng SP, Bahig H, Wang J, Cardenas CE, Lucci A, Hall CS, Meas S, Sarli VN, Yuan Y, Urbauer DL, Ding Y, Ikner S, Dinh V, Elgohari BA, Johnson JM, Skinner HD, Gunn GB, Garden AS, Phan J, Rosenthal DI, Morrison WH, Frank SJ, Hutcheson KA, Mohamed ASR, Lai SY, Ferrarotto R, MacManus MP, Fuller CD. Predicting treatment Response based on Dual assessment of magnetic resonance Imaging kinetics and Circulating Tumor cells in patients with Head and Neck cancer (PREDICT-HN): matching 'liquid biopsy' and quantitative tumor modeling. BMC Cancer. 2018 Sep 19;18(1):903. doi: 10.1186/s12885-018-4808-5.