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

NCT04040166 | Completed

• 1 other identifier: 18-6313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Head & Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PET/MRI scan with 68Ga DOTATATE

OTHER

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

Interventions

PET/MRI of carotid arteries with 68Ga DOTATATE DIAGNOSTIC_TEST

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

PET/MRI scan with 68Ga DOTATATE

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Patrick Veit-Haibach, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapy

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: August 22, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

CA (1)