Functional Sparing of Salivary Glands Using MRI Sialography for Patients Undergoing Definitive Radiation Therapy for Head and Neck Cancers of the Oropharynx
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | March 8, 2018 |
| End Date: | March 2021 |
| Contact: | David V. Fried, PhD |
| Email: | david_fried@med.unc.edu |
| Phone: | 984-974-8717 |
The proposed study is an attempt to improve patient xerostomia (dry mouth) after definitive
radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced
symptom for those receiving radiation therapies to the head and neck that persists after
treatment, potentially indefinitely. It has been shown that stem/progenitor cells
preferentially reside in large ducts of salivary glands and that these cells have the ability
to repair radiation induced salivary damage. Current practice does not specifically attempt
to spare these regions and considers the entire salivary gland to have equal importance and
function. This study will involve the acquisition of pre-treatment MRI sialogram images which
enable visualization of salivary ducts (using saliva itself as a contrast agent) that can
then be avoided during radiation treatment planning. The primary objective will be to obtain
patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a
historical cohort. Xerostomia symptom information will be obtained by use of a patient
reported quality of life survey administered prior to treatment, six months after treatment,
and one year after treatment. The secondary objectives will be to quantitatively assess
post-treatment changes in salivary gland volume as well as ductal visibility using MRI
sialograms. The study team hopes to acquire pre- and post-treatment images from 40 patients.
The investigator hypothesizes that reducing the dose to these stem cell containing salivary
ducts will facilitate improvements in patient reported symptoms as well as improved recovery
of salivary gland volume and intra-glandular ductal visibility using MRI sialograms.
radiation therapy treatment for head and neck cancer. Xerostomia is a frequently experienced
symptom for those receiving radiation therapies to the head and neck that persists after
treatment, potentially indefinitely. It has been shown that stem/progenitor cells
preferentially reside in large ducts of salivary glands and that these cells have the ability
to repair radiation induced salivary damage. Current practice does not specifically attempt
to spare these regions and considers the entire salivary gland to have equal importance and
function. This study will involve the acquisition of pre-treatment MRI sialogram images which
enable visualization of salivary ducts (using saliva itself as a contrast agent) that can
then be avoided during radiation treatment planning. The primary objective will be to obtain
patient reported outcomes (PRO) measure of xerostomia related symptoms for comparison with a
historical cohort. Xerostomia symptom information will be obtained by use of a patient
reported quality of life survey administered prior to treatment, six months after treatment,
and one year after treatment. The secondary objectives will be to quantitatively assess
post-treatment changes in salivary gland volume as well as ductal visibility using MRI
sialograms. The study team hopes to acquire pre- and post-treatment images from 40 patients.
The investigator hypothesizes that reducing the dose to these stem cell containing salivary
ducts will facilitate improvements in patient reported symptoms as well as improved recovery
of salivary gland volume and intra-glandular ductal visibility using MRI sialograms.
Inclusion Criteria:
- At least 18 years of age
- T0-4, N0-3, M0 squamous cell carcinoma of the oropharynx
- Will be treated with IMRT and with definitive intent (either definitive or
postoperative radiotherapy)
- Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks
prior to treatment; at a minimum, chest x-ray is required (CT imaging of the chest or
PET/CT is acceptable)
- ECOG Performance Status 0-2
- Negative pregnancy test within 2 weeks prior to treatment for women of childbearing
potential
- Able to comply with the treatment plan and follow-up schedule
- Able to provide study-specific informed consent provided prior to study entry
Exclusion Criteria:
- Any contraindications to receiving an MRI such as: implanted electrical devices,
pregnancy, and/or significant quantities of metal in the head/neck
- Sjorgen's syndrome or baseline xerostomia (CTCAE > 0 for question regarding dry mouth)
- Lesions grossly involving the salivary glands
- Allergy to lemon juice
- Prior history of radiation therapy to the head and neck
- Pre-treatment scan deemed not usable
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: David V. Fried, PhD
Phone: 984-974-8717
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