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MRI + Biomarkers for Throat Cancer

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function: Calculated creatinine clearance >/= 30ml/min

Histologically proven Head and Neck Squamous Cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to radiotherapy, week 2 and week 4 of radiotherapy

Awards & highlights

Study Summary

This trial looks at biomarkers to help diagnose and treat people with a type of throat cancer called HNSCC.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of Head and Neck Squamous Cell Carcinoma, who can lie on their back for an hour and are set to receive curative therapy. They must be able to understand the study details and consent, have decent kidney function, and not have had another solid tumor treated in the last five years or any condition that would exclude them from MRI scans.Check my eligibility

What is being tested?

The HN-BIO study is testing how well functional MRI (fMRI) imaging combined with a drug called Oral Pimonidazole works as biomarkers in patients undergoing treatment for head and neck cancer. The goal is to improve understanding of the tumor environment which could lead to better treatments.See study design

What are the potential side effects?

Potential side effects may include discomfort from lying still during fMRI scans, reactions related to Oral Pimonidazole such as nausea or allergic responses, and risks associated with repeated exposure to gadolinium contrast if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough (creatinine clearance is 30ml/min or more).

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I have been diagnosed with squamous cell carcinoma in the head or neck.

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My cancer or its nodes are larger than 3cm.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to radiotherapy, week 2 and week 4 of radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to radiotherapy, week 2 and week 4 of radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to radiotherapy, week 2 and week 4 of radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in fMRI during radiotherapy

Change in tumor microenvironment during radiotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions

Participants who are to receive standard of care curative surgery will have an MRI scan within one week prior to surgery. Tumor tissue from the surgery will also be collected for research. Oral pimonidazole will be taken the night before surgery.

Group II: Cohort AExperimental Treatment2 Interventions

Participants who are to receive standard of care radiotherapy will have one biopsy and MRI scan before starting radiotherapy and during week two of radiotherapy. Participants will also have an the option to consent to an additional biopsy and MRI scan during week 4 of radiotherapy. Oral pimonidazole will be taken the night before each biopsy.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this medical experiment open to participants?

"The details available on clinicaltrials.gov indicate that this particular trial is not presently open for enrollment, despite being initially posted in December 15th 2023 and edited most recently on October 9th 2023. However, there are 504 additional trials with recruitment currently underway."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

2024. "HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085781.

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