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
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
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).
- 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.
- 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.
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
|Contact: Amita Dave, PhDemail@example.com|
|Contact: Alan Ho, MD, PhD||646-888-4235|
|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|
|Principal Investigator:||Amita Dave, PhD||Memorial Sloan Kettering Cancer Center|