Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy

Head & Neck Cancer Clinical Trial

Official title:

PET/MR of the Carotid Arteries With 68Ga DOTATATE in Patients Following Head and Neck Radiation Therapy and at Risk of Cerebrovascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040166
• Other study ID #: 18-6313
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: April 15, 2021

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The improvement of comprehensive multi-modality treatment and radiotherapy (RT) technology has resulted in an improved survival rate of head and neck malignancies within recent decades. As survival increases, late toxicity from cancer therapy becomes a larger burden. Radiation induced vascular injury following RT is a recognized complication of radiotherapy. Diagnosis of vascular changes predominately relies on non-invasive imaging techniques. Doppler ultrasound assessment has been proven as a good indicator of diffuse atherosclerotic disease and a significant predictor of future vascular events. New opportunities are provided by the recent introduction of the hybrid PET/MRI scanners for investigating the synergistic effect of these two modalities without the challenge of image co-registration. It has been shown that the PET system integrated with the MRI scanner performs the same as the PET portion of a PET/CT for various cancers and cardiovascular indications. MRI allows better delineation of the carotid artery and atherosclerotic plaque when compared with CT due to the superior soft tissue contrast. The PET/MRI system acquires the PET and MRI simultaneously allowing for perfect alignment between the 2 sets of images, when compared with the sequential acquisition in PET/CT where minor head movements can cause misalignment. There is evidence in the literature that 68-Ga DOTA-TATE PET-imaging can serve as a surrogate marker for evidence of invasion into the vessel wall and thereby possibly detects early, developing atherosclerotic plaque. Thus, combined PET and MR with 68-Ga DOTA-TATE should be a promising imaging tool to screen and characterize patients at risk for radiation induced carotid injury.

In this study, DOTATATE-PET/MR will be performed in up to 60 patients with a history of radiation therapy for head and neck squamous cell carcinoma over 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• previously treated with radiation for head and neck malignancy;

• Age Group: =30 years;

• Patients who have no contraindications to PET/MRI;

• No allergy to contrast agents.

Exclusion Criteria:

• Pregnant females;

• Age group: < 30 years;

• Allergy to MR contrast agents;

• Pacemakers/ICD/Claustrophobic patients.

Related Conditions & MeSH terms

• Head & Neck Cancer
• Head and Neck Neoplasms

Intervention

Diagnostic Test:
• PET/MRI of carotid arteries with 68Ga DOTATATE
PET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of PET/MRI with 68Ga DOTATATE of carotid arteries	Macrophage activity detected by 68Ga DOTATATE PET/MRI of carotid arteries in patients at risk for vascular events post radiation of head and neck squamous cell carcinoma.	complete of enrollment, an average of two years