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

NCT03286972 | Terminated DMC

• 5 other identifiers: UW160642017-0162A533300SMPH\HUMAN ONCOLOGY\HUMAN ONCONCI-2019-05974
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants able to complete the PET/MRI examination

  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.

  Up to 1 year

Secondary Outcomes (4)

• Changes in staging between PET/CT and PET/MRI

  Up to 1 year

• Feasibility of PET/MRI in radiation treatment planning workflow

  Up to 1 year

• Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality

  Up to 1 year

• Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV)

  Up to 1 year

Study Arms (1)

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

Interventions

PET/MRI 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

PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• UW Carbone Cancer Center home page

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Paul M Harari, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: September 12, 2017
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-06

Locations

US (1)