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New MRI Biomarkers in Head and Neck Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483337
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.

The purpose of this study is to see if new MRI methods can give us more information about the tumor.


Condition or disease Intervention/treatment
Head and Neck Cancer Other: MRI examinations

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Imaging Tools to Derive DW-MRI Oncological Biomarkers
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
recurrent or metastatic head and neck cancer patients
Patients will be imaged on a 1.5 T or 3 T MR scanner. Patients will receive a test-retest DWI scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at Memorial Sloan Kettering's main campus, will also be imaged weekly during their course of treatment.
Other: MRI examinations
Patients will be imaged on a 1.5 T or 3 T MR scanner either from GE or Philips. Patients will receive a test-retest scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at main campus, will also be imaged weekly during their course of treatment.

head and neck cancer or thyroid cancers
All patients, irrespective of treatment regimen, will be imaged on a 1.5T or 3T MR scanner prior to treatment initiation. Follow up imaging for patients undergoing surgery only will be as per clinical standard of care and not on this protocol. Patients undergoing treatment in radiation oncology and/or medicine will have imaging studies at two months (60 days) and four months (120 days) after completion of all treatments, including systemic therapy if (+/- 2 weeks or 14 days). Imaging on or immediately after systemic therapy treatment (+/- 2 weeks or 14 days) to derive MRI biomarkers indicative of therapeutic mechanisms of action or efficacy will also be performed. Patients who will be receiving radiation therapy treatment will also have recommended weekly imaging during their course of treatment.
Other: MRI examinations
Patients will be imaged on a 1.5 T or 3T MR scanner within one week prior to treatment initiation and at two months and four months after treatment completion (+/- 1 week).




Primary Outcome Measures :
  1. For group 1: number of patients that have biomarkers that maybe early response to therapy indicators [ Time Frame: 1 year ]
    The study is designed to determine if the MRI will provide quantitative imaging biomarkers to predict or assess early treatment response in R/M head and neck cancers. The MR data will be compared with clinical follow-up data. Additional sequence parameters.

  2. For group 2: number of patients response to treatment [ Time Frame: 1 year ]
    will be assessed using ROC curves with RECIST with the RECIST version 1.1 response as the gold standard and change in DW-MRI and image feature metrics as predictors.



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
Sampling Method:   Non-Probability Sample
Study Population
MSK clinics in the medicine, surgery and radiation oncology departments.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region.
  • Group 2 patients:

    • Biopsy proven recurrent or metastatic or definitive head and neck cancer or thyroid cancer in the head and neck region only.
    • Patients planning to undergo reatment at MSK

Exclusion Criteria:

  • Patient would require anesthesia for the study
  • Patients who are claustrophobic
  • Patients selecting treatment outside of MSK
  • Known reaction to Gd based contrast agent
  • Patients who have presence of a known contradiction to MRI

    • Pacemaker
    • Aneurysm clips
    • Patients with implants that are contradicted for MR imaging will be excluded
    • Pregnant
    • Age and mental status wherein he /she is unable to cooperate for MRI study

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): NCT03483337


Contacts
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Contact: Amita Dave, PhD 212-639-3184 davea@mskcc.org
Contact: Alan Ho, MD, PhD 646-888-4235

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Amita Dave, PhD    212-639-3184      
Contact: Alan Ho, MD, PhD    646-888-4235      
Principal Investigator: Amita Dave, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Amita Dave, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03483337    
Other Study ID Numbers: 18-063
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
(DW)-MRI
oncological biomarkers
metastatic
recurrent
18-063
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms