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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04040166
Collaborator
(none)
60
1
1
27.3
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapyCarotid PET/MRI With DOTATATE in patients post head and neck radiation therapy
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Aug 22, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: PET/MRI scan with 68Ga DOTATATE

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Network Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Patrick Veit-Haibach, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04040166
Other Study ID Numbers:
  • 18-6313
First Posted:
Jul 31, 2019
Last Update Posted:
Sep 3, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 3, 2020