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

NCT ID: NCT03286972

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-12
• Study Completion Date: 2019-06-20

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.

Conditions

Head and Neck Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

PET/MRI

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul M Harari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.uwhealth.org/uw-carbone-cancer-center/47424

UW Carbone Cancer Center home page

Other Identifiers

2017-0162

Identifier Type: OTHER

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCOLOGY\HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-05974

Identifier Type: REGISTRY

Identifier Source: secondary_id

UW16064

Identifier Type: -

Identifier Source: org_study_id