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

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ClinicalTrials.gov Identifier: NCT03491176
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
Radiological Society of North America
The Royal Australian and New Zealand College of Radiologists
Information provided by (Responsible Party):
M.D. 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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: MRI Procedure: Blood Draw Behavioral: Questionnaires Not Applicable

Detailed Description:

Study Visits:

If participant is found to be eligible to take part in this study, participant will have the following tests and procedures performed.

If participant is receiving chemotherapy before radiation therapy, blood (about 3 teaspoons) will be drawn for biomarker testing before participant starts chemotherapy and then before each cycle of chemotherapy until participant starts radiation therapy.

For all participants, the following tests and procedures will be performed before participant starts radiation therapy:

  • Participant will have an MRI.
  • Blood (about 3 teaspoons) will be drawn for biomarker testing.
  • Participant will complete a questionnaire about participant's quality of life. Completing this questionnaire should take about 5-10 minutes.

Treatment is given outside of the study, as recommended by participant's doctor. Taking part in the study will not affect participant's treatment plan.

After participant's first radiation treatment, blood (about 3 teaspoons) will be drawn for biomarker testing.

Every week while participant is receiving radiation therapy:

  • Participant will have a physical exam and endoscopy.
  • Blood (about 3 teaspoons) will be drawn for routine and biomarker testing.

Every week during radiation therapy:

  • Participant will have an MRI. This may be done as often as 1 time a day during radiation therapy if participant is having image-guided radiation therapy (GRT).
  • Participant will complete the quality-of-life questionnaire.

Wherever possible, blood samples will be collected at the same time as routine blood draws and/or when a catheter (needle and tube) is placed. However, if a blood draw is not planned, one will be scheduled for this study.

Length of Study:

Participation on the study will be over after the follow-up visit. Participant will be taken off study early if radiation treatment is stopped early.

Follow-up:

One (1) time a week for as long as needed during routine follow-up, participant will complete the quality-of-life questionnaire.

At 2-3 months after treatment:

  • Participant will have a physical exam and endoscopy.
  • Blood (about 3 teaspoons) will be drawn for routine and biomarker testing.
  • Participant will have a CT, MRI, and PET/CT scan to check the status of the disease.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI and Biomarker Testing Procedure: MRI
Participants receive an MRI before radiation therapy, every week during radiation, and 2-3 months after completion of radiation therapy.
Other Name: Magnetic resonance imaging

Procedure: Blood Draw

If participants receive chemotherapy, blood draws performed for biomarker testing before the start chemotherapy, and then before each cycle of chemotherapy until participant starts radiation therapy.

All participants, blood drawn for biomarker testing before the start of radiation therapy, after the first radiation treatment, every week during radiation treatment, and 2-3 months after radiation treatment.


Behavioral: Questionnaires
Quality of life questionnaire completed before start of radiation therapy, every week during radiation therapy, and one time a week during follow up.
Other Name: Surveys




Primary Outcome Measures :
  1. Tumor Growth Velocity (TGV) [ Time Frame: Baseline and up to 2-3 months after completion of radiation therapy. ]
    TGV calculated by increase in tumor size from diagnosis to immediately before first RT treatment as measured via MRI.

  2. Tumor Kinetics (TK) [ Time Frame: Baseline and up to 2-3 months after completion of radiation therapy. ]
    Tumor kinetics defined as weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI.

  3. Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT) [ Time Frame: Baseline and up to 2-3 months after completion radiation treatment. ]
    Blood biomarkers of interest are circulating tumor cells (CTCs).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Age ≥18 years
  3. No distant metastases, based on routine staging workup.
  4. Consent for blood collection for biomarker analysis
  5. No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
  6. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  7. Dispositioned to curative intent radiotherapy
  8. For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

  1. Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
  2. Pregnant or breast-feeding females
  3. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators)
  4. History of claustrophobia
  5. Contraindications to gadolinium contrast (e.g. kidney dysfunction)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491176


Contacts
Contact: Clifton Fuller, MD, PHD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Radiological Society of North America
The Royal Australian and New Zealand College of Radiologists
Investigators
Principal Investigator: Clifton Fuller, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03491176     History of Changes
Other Study ID Numbers: PA16-1041
RF1701 ( Other Grant/Funding Number: Radiological Society of North America (RSNA) )
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Magnetic resonance imaging
MRI
Biomarker testing
Blood draws
Questionnaires
Surveys

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms