Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-27
Brief Title:
A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HN-Bio 02
Brief Summary:
This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed head and neck squamous cell carcinoma HNSCC receiving curative therapy This research is part 2 of the HN-BIO study
Detailed Description:
This study will recruit up to 40 patients planned to receive curative chemo radiotherapy for head and neck squamous cell carcinoma HNSCC with primary tumor andor involved lymph node suitable for repeat biopsy in clinic After being informed about the study and potential risks patients giving written informed consent will be randomized to receive conventional radiotherapy single integrated boost or conventional two-phase at clinician discretion or reversed two-phase treatment with delayed irradiation of elective nodal volumes Patients will not be informed of their randomization result
Patients in both arms will undergo a baseline functional magnetic resonance imaging fMRI scan and within 72 hours when possible a biopsy of the primary tumor - lymph node will be performed in an out-patient clinic If a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible In week 2 of radiotherapy patients will have a second fMRI scan and a paired biopsy within 72 hours of the scan where possible A further optional biopsy and paired fMRI scan in week 4 will be considered for patients who are tolerating therapy without G1 toxicities 16-24 hours prior to each biopsy the patient will take oral pimonidazole At the time of each biopsy a blood draw will be performed
Patients in both arms will undergo a baseline functional magnetic resonance imaging fMRI scan and within 72 hours when possible a biopsy of the primary tumor - lymph node will be performed in an out-patient clinic If a suitable biopsy has been recently performed as part of diagnostic work up the baseline biopsy on study will be omitted when possible In week 2 of radiotherapy patients will have a second fMRI scan and a paired biopsy within 72 hours of the scan where possible A further optional biopsy and paired fMRI scan in week 4 will be considered for patients who are tolerating therapy without G1 toxicities 16-24 hours prior to each biopsy the patient will take oral pimonidazole At the time of each biopsy a blood draw will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None