Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001523
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation
Status:
COMPLETED
Status Verified Date:
1999-06
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:
None
Brief Summary:
Therapeutic irradiation to the head and neck for cancer damages salivary glands present in the radiation field Despite long recognition of radiation-induced salivary hypofunction and the associated oral morbidities the specific damage mechanisms is not known and the structure and functional integrity of the surviving parenchymal tissue has not been well-documented Detailed knowledge of the latter is particularly necessary in order to design appropriate corrective therapies It is the purpose of this study to provide such a detailed structural and functional assessment of human parotid glands following irradiation The study will examine 20 patients beginning just prior to therapeutic irradiation and continuing at intervals for 3 years for a total of 5 study visits Study visits prior to irradiation and at 4 weeks 12 weeks 12 months and 36 months post-irradiation will include the following procedures i detailed oral exam and structured interview ii salivary gland functional assessment iii sialography of each parotid gland iv 99mTcO4 scan of the salivary glands and v a magnetic resonance imaging MRI scan of the parotid glands Based on previous single observation studies in humans and more detailed animal studies we hypothesize that ionizing radiation will lead to reduced parotid gland function and diminished salivary parenchymal tissue with a preferential loss in acinar versus ductal cells Further we hypothesize that the parenchymal loss will increase with time replaced by fat and connective tissue and lead to progressive irreversible salivary dysfunction
Detailed Description:
Therapeutic irradiation to the head and neck for cancer damages salivary glands present in the radiation field Despite long recognition of radiation-induced salivary hypofunction and the associated oral morbidities the specific damage mechanisms is not known and the structure and functional integrity of the surviving parenchymal tissue has not been well-documented Detailed knowledge of the latter is particularly necessary in order to design appropriate corrective therapies It is the purpose of this study to provide such a detailed structural and functional assessment of human parotid glands following irradiation The study will examine 20 patients beginning just prior to therapeutic irradiation and continuing at intervals for 3 years for a total of 5 study visits Study visits prior to irradiation and at 4 weeks 12 weeks 12 months and 36 months post-irradiation will include the following procedures i detailed oral exam and structured interview ii salivary gland functional assessment iii sialography of each parotid gland iv 99mTcO4 scan of the salivary glands and v a magnetic resonance imaging MRI scan of the parotid glands Based on previous single observation studies in humans and more detailed animal studies we hypothesize that ionizing radiation will lead to reduced parotid gland function and diminished salivary parenchymal tissue with a preferential loss in acinar versus ductal cells Further we hypothesize that the parenchymal loss will increase with time replaced by fat and connective tissue and lead to progressive irreversible salivary dysfunction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-D-0082 | None | None | None |