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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03286972
• Other study ID #: UW16064
• Secondary ID: 2017-0162A533300
• Status: Terminated
• Start date: September 12, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in staging between PET/CT and PET/MRI	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.	Up to 1 year
Secondary	Feasibility of PET/MRI in radiation treatment planning workflow	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.	Up to 1 year
Secondary	Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality	Pulse sequences will be assess with Wilcoxon signed rank test.	Up to 1 year
Secondary	Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV)	Differences in simulated radiation treatment planning volumes will be assess with Wilcoxon signed rank test.	Up to 1 year

External Links

•   UW Carbone Cancer Center home page