Tongue Cancer Clinical Trial
Official title:
Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen
This is a pilot study in the form of a prospective Phase II, single centre, single arm hypoxia study of oral tongue cancer with FAZA-PET imaging and pimonidazole targeted IHC of surgical specimens.
In head and neck cancer, areas of tumours with low oxygen supply (called tumour hypoxia) harbour cells that are resistant to radiation and are prone to metastasize. Modern radiotherapy techniques are precise enough to deliver radiation to these small areas and could be used to target these areas to receive higher doses of radiation than the rest of the tumour to overcome resistance. Hypoxia can be "seen" in the body using special imaging such as [F-18]-FAZA-PET ([F-18]-Fluoroazomycin arabinoside positron emission tomography) but it has not been tested as a method for creating radiation treatment targets. As part of regular pathology tumour tissue is sliced extremely thinly (<1/100th of a millimeter) and stained so that individual cells can be seen under a microscope. Immunohistochemistry (IHC) is a special type of "stain" that can specifically highlight hypoxic areas. This method is considered the most accurate way to inspect for the presence of hypoxia. There is not a specific staining target for hypoxia ordinarily, but when patients ingest a substance called pimonidazole hydrochloride (HCl) it builds up specifically in hypoxic areas and can be targeted for IHC staining. In this study participants with oral tongue cancer will have a [F-18]-FAZA-PET scan and take a single dose of oral pimonidazole-HCl before having surgery to remove their cancer. The whole tumour will be used to create microscope slides using very thin slices of the tumour. The slices will be stained using IHC to show where the pimonidazole has built up and digital scans of the slides will be made. The hypoxia seen on the FAZA-PET scan will be "matched" with hypoxia on the electronic slides to see if the FAZA truly shows where hypoxia is in tumours and if it could be used as a way to plan radiation treatments to deliver more radiation to just those areas. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01469429 -
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04041141 -
Oral Stent Device for Radiation Treatments of Oral Cancers
|
||
| Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00096512 -
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00033618 -
Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
| Completed |
NCT01816841 -
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
|
N/A | |
| Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
| Completed |
NCT04059861 -
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin
|
N/A | |
| Recruiting |
NCT01854021 -
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
|
N/A | |
| Completed |
NCT01816984 -
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01674374 -
Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
|
Phase 2 | |
| Terminated |
NCT01528137 -
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT04337853 -
Radiotherapy of Tongue Cancer Using an Intraoral Stent
|
Phase 1 | |
| Completed |
NCT01806675 -
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01847326 -
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
|
Phase 1 | |
| Terminated |
NCT02177838 -
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
|
N/A | |
| Completed |
NCT00114283 -
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT04126226 -
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
|
N/A |