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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05919290
Other study ID # 22-5864
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2023
Est. completion date July 1, 2026

Study information

Verified date August 2023
Source University Health Network, Toronto
Contact Rehab Chahin, MD
Phone 416-946-4501
Email Rehab.Chahin@uhn.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed HNSCC (Head and Neck Squamous Cell Carcinoma) receiving curative therapy. The study will consist of two prospective arms. In Arm 1 up to 100 HNSCC patients receiving (CT)RT (computed tomography-based radiation therapy) will receive up to weekly non-contrast MRI (magnetic resonance imaging) scans during treatment. Arm 2 consists of two cohorts. In cohort A up to 20 healthy volunteers will undergo non-contrast MRI at two time points. In cohort B up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.


Description:

The purpose of this study is to develop and investigate novel and established MR (magnetic resonance) imaging sequences as predictive and prognostic radiotherapy biomarkers. Radiotherapy is a fundamental treatment modality for Head and Neck Squamous Cell Carcinoma (HNSCC) with a majority of patients receiving radiation as part of their care pathway. Although treatment is effective, there remains a risk of failure particularly in those presenting with locally advanced disease. In addition, significant proportion of patients receiving radiotherapy will suffer long-term side effects related to their treatment. The addition of concurrent chemotherapy improves the efficacy of radiotherapy, but at the cost of increased treatment related toxicity. The treatment related toxicity and risk of treatment failure means there is a compelling clinical need to personalize therapy based on a patient's early response to radiotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 173
Est. completion date July 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for Cancer Patients: - Age >/= 18 years - Histologically proven Head and Neck Squamous Cell carcinoma - Primary or nodal disease > 3cm for biomarker imaging - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 - Planned for curative surgery or (chemo)radiotherapy - Willingness to undergo repeat MRI - Able to receive and understand verbal and written information regarding study and able to give written informed consent - Adequate renal function: Calculated creatinine clearance >/= 30ml/min - Be able to lie comfortably on back for 1 hour Exclusion Criteria for Cancer Patients: - As judged by investigator evidence of systemic disease that makes unsuitable for study - Contra-indication for serial MRI scans - Previous solid tumor treated within last 5 years - Pregnancy - History of significant obstructive airway disease - History of gadolinium contrast allergy Inclusion Criteria for Healthy Volunteers - Age >/= 18 years - Able to receive and understand verbal and written information regarding study and able to give written informed consent - Willingness to undergo repeat MRI Exclusion Criteria for Healthy Volunteers - Unwillingness to sign informed consent - Contra-indication for MRI - Underlying significant respiratory disease

Study Design


Related Conditions & MeSH terms

  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
MRI
Non-invasive imaging technique that is used to take pictures of organs within the body.

Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC) Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy
Primary Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI fMRI images will be used to evaluate on treatment tumour response to determine the effect of dose escalation to tumor sub regions using a daily online adaptive radiation treatment approach Weekly MRI imaging during radiotherapy (Up to 7 weeks)
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