Clinical trial NCT03286972: PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Official title: PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percentage of participants able to complete the PET/MRI examination
timeFrame: Up to 1 year
Secondary outcomes:
measure: Changes in staging between PET/CT and PET/MRI
timeFrame: Up to 1 year
measure: Feasibility of PET/MRI in radiation treatment planning workflow
timeFrame: Up to 1 year
measure: Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality
timeFrame: Up to 1 year
measure: Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul M Harari, MD
role: PRINCIPAL_INVESTIGATOR
References: