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

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ClinicalTrials.gov Identifier: NCT04040166
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Head & Neck Cancer Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : August 22, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Validity of PET/MRI with 68Ga DOTATATE of carotid arteries [ Time Frame: 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040166


Contacts
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Contact: Patrick Veit-Haibach, MD 416-340-4800 ext 6085 Patrick.Veit-Haibach@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Patrick Veit-Haibach         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Patrick Veit-Haibach, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04040166    
Other Study ID Numbers: 18-6313
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms