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Completed

NCT Number: NCT04040166

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2019
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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