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

Not Applicable

Completed

• Conditions: Head & Neck Cancer
• Interventions: Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE

• Registration Number: NCT04040166
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Study Start: 2019-08-22
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• Pregnant females;
• Age group: < 30 years;
• Allergy to MR contrast agents;
• Pacemakers/ICD/Claustrophobic patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MRI scan with 68Ga DOTATATE	PET/MRI of carotid arteries with 68Ga DOTATATE	PET/MRI scan with 68Ga DOTATATE of carotid arteries in in patients following head and neck radiation therapy

Primary Outcome Measures

Name	Time	Method
Validity of PET/MRI with 68Ga DOTATATE of carotid arteries	complete of enrollment, an average of two years	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada