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

Study Overview
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Brief Summary
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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.

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

Conditions
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Head & Neck Cancer

Intervention / Treatment
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* Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PET/MRI scan with 68Ga DOTATATE<br>PET/MRI scan with 68Ga DOTATATE of carotid arteries in in patients following head and neck radiation therapy | Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE<br>* PET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |