Head & Neck CancerNCT04040166
Carotid PET/MRI With DOTATATE in Patients Post Head and Neck Radiation Therapy
A study testing PET/MRI of carotid arteries with 68Ga DOTATATE in people with Head & Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- PET/MRI of carotid arteries with 68Ga DOTATATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2019to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant females;
- Age group: < 30 years;
- Allergy to MR contrast agents;
- Pacemakers/ICD/Claustrophobic patients.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PET/MRI of carotid arteries with 68Ga DOTATATE
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI of carotid arteries with 68Ga DOTATATEDiagnostic test
PET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: complete of enrollment, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start22 Aug 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040166
- Sponsor's protocol ID
- 18-6313
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04040166
- Acronym / sponsor ID
- 18-6313
- Conditions
- Head & Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Carotid PET/MRI With DOTATATE in patients post head and neck radiation therapy
| Arm | Type | Receives |
|---|---|---|
| PET/MRI scan with 68Ga DOTATATE | Other | Diagnostic Test: PET/MRI of carotid arteries with 68Ga DOTATATEPET/MRI scan with 68Ga DOTATATE of carotid arteries in in patients following head and neck radiation therapy |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant females;
- Age group: < 30 years;
- Allergy to MR contrast agents;
- Pacemakers/ICD/Claustrophobic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRI of carotid arteries with 68Ga DOTATATEPET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy | Diagnostic test | PET/MRI scan with 68Ga DOTATATE |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Related trials for Head & Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI of carotid arteries with 68Ga DOTATATE in people with Head & Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of PET/MRI with 68Ga DOTATATE of carotid arteries (time frame: complete of enrollment, an average of two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.