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Trial record 100 of 1321 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning

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ClinicalTrials.gov Identifier: NCT03286972
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

The purpose of this study is to evaluate this new technology available at the University of Wisconsin Carbone Cancer Center in the setting of head and neck cancer radiation treatment planning. This study will also provide preliminary data critical to the development of multi-parametric, multi-modality quantitative imaging biomarkers and data analysis models for prediction of outcome in both tumors and normal tissue, which are essential for patient-specific adaptive therapy.

All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per SOC procedures. In addition, all participants will undergo an additional imaging set consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the same day as their PET/CT negating the need for a second injection of the FDG radioisotope used for SOC PET imaging. All patients will receive gadolinium contrast per SOC dosing guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and investigational sequences will be utilized in this study.


Condition or disease Intervention/treatment
Head and Neck Neoplasms Device: PET/MRI

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PET/MRI

All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per SOC procedures. In addition, all participants will undergo an additional imaging set consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the same day as their PET/CT negating the need for a second injection of the FDG radioisotope used for SOC PET imaging. All participants will receive gadolinium contrast per SOC dosing guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and investigational sequences will be utilized in this study.

If a second dose of the radioisotope is need to complete the PET/MRI (unable to perform both PET scans on the same day) only a 50% dose of FDG will be administered due to the increased sensitivity the PET/MRI scanner.

Device: PET/MRI
Participants will be placed in standard non-ferrous head and neck immobilization devices during PET/MRI (to simulate their anticipated positioning during subsequent CT simulation and treatment). A head/neck PET/MRI (standard bore size, 60 cm) will be performed




Primary Outcome Measures :
  1. Percentage of participants able to complete the PET/MRI examination [ Time Frame: Up to 1 year ]
    Identify the percentage of head and neck cancer patients who are able to successfully complete or partially complete the PET/MRI examination. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.


Secondary Outcome Measures :
  1. Changes in staging between PET/CT and PET/MRI [ Time Frame: Up to 1 year ]
    Compare changes in tumor and regional staging between PET/CT and PET/MRI. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.

  2. Feasibility of PET/MRI in radiation treatment planning workflow [ Time Frame: Up to 1 year ]
    Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of image quality and image fusion of PET/MRI data with the treatment planning CT, as compared to PET/CT.

  3. Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality [ Time Frame: Up to 1 year ]
    Pulse sequences will be assess with Wilcoxon signed rank test.

  4. Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV) [ Time Frame: Up to 1 year ]
    Differences in simulated radiation treatment planning volumes will be assess with Wilcoxon signed rank test.



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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:   Probability Sample
Study Population
The planned enrollment of 40 participants includes 4-12 patients in each of the 5 anatomic subgroups. This will allow flexibility in enrollment to reflect the frequency pattern of case presentation and any early findings that may suggest one or more sub-sites are particularly well suited to disclose valuable tumor data using PET/MRI scans.
Criteria

Inclusion Criteria:

  • Participants with tumors of the head and neck region (nasal cavity, oral cavity, pharynx, larynx, sinuses, salivary glands, and head and neck skin) who are candidates for radiation treatment.

Exclusion Criteria:

  • Contraindications for MRI: All patients will be screened with standard UWHC MRI screening procedures:
  • Any person with the following will be excluded: cardiac pacemaker, metal fragments in or around the eye, venous umbrella, permanent eyeliner or permanent artificial eyebrows.

Patents with the following potentially non-MRI compatible devices will undergo screening using the standard UWHC MRI screening protocol by trained UWHC personnel: cardiac pacemaker, heart valve replacement, intracranial aneurysm clips, middle ear, eye, joint, or penile implants, joint replacements, implantable hearing aids, neurostimulator devices, insulin pumps, shunts/stents, metal mesh/coil implants; metal plate/pin/screws/wires, or any other metallic implants. Also patients with anatomical constraints limiting the feasibility of MRI will be excluded.

- Issue of pregnancy: We will exclude all known pregnant females from the study to avoid the potential risk of fetal injury upon exposure to the PET scan. Determination of pregnancy will be based upon the standard screening procedures in place for radiation therapy.

  • Persons who are not fluent in English
  • Anyone who can not provide written informed consent

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): NCT03286972


Contacts
Contact: Cancer Connect 8006228922 cancerconnect@uwcarbone.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Principal Investigator: Paul Harari, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul M Harari, MD University of Wisconsin, Madison

Additional Information:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03286972     History of Changes
Other Study ID Numbers: UW16064
P30CA014520 ( U.S. NIH Grant/Contract )
2017-0162 ( Other Identifier: Institutional Review Board )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

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

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