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

Head and Neck Cancer Clinical Trial

Official title:

Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03491176
• Other study ID #: PA16-1041
• Secondary ID: NCI-2018-02631PA
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 18, 2017
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Head and Neck Cancer
• Head and Neck Neoplasms
• Healthy Subject
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
• Magnetic Resonance Imaging
Undergo MRI scan

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor growth velocity (TGV)	TGV is the calculated daily increase in tumor size from diagnosis to immediately before first radiotherapy (RT) treatment as measured via magnetic resonance imaging (MRI). Will use graphs and descriptive statistics to evaluate the relationship between TGV, tumor kinetics (TK), and circulating tumor cells (CTCs) with response.	Baseline and up to 2-3 months after completion of radiation therapy
Primary	Change in TK	Tumor kinetics is the weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI. Will also use generalized linear mixed models (GLMMs) to evaluate TK over time and to assess whether a difference exists between patients with complete response (CR) and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.	Baseline up to 2-3 months after radiation therapy
Primary	Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)	Will use GLMMs to evaluate CTCs over time and to assess whether a difference exists between patients with CR and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.	Baseline and up to 2-3 months after completion radiation treatment.
Secondary	Locoregional control	Locoregional control is defined as 2-year disease-free survival (DFS). Proportional hazards models will be created to examine the trajectory and intercept of TK and CTCs during radiation therapy with DFS. Time-varying covariates longitudinal modeling will be used to assess the relationship between TK and CTCs.	From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years

External Links

•   MD Anderson Cancer Center Website