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NCT00001523 · ClinicalTrials.gov registry record

Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation

A clinical trial, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

Completed
Registry status
20
Enrollment target

NCT00001523: Completed study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

NCT00001523 is a clinical trial that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001523 has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

COMPLETED
Registry status
20 participants
Enrollment target

Study 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 mechanism(s) 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.

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 1996-05
Est. Completion 2000-03

What the finished NCT00001523 record still lists

NCT00001523 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00001523 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001523 about?

NCT00001523 is a clinical study titled "Structure and Functional Status of Parotid Glands Exposed to Therapeutic Irradiation". 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 mechanism(s) is not known and the structure and functional int...

What is the current status of trial NCT00001523?

This trial is currently completed. The enrollment target is 20 participants. The study started on 1996-05. Estimated completion is 2000-03.

Who is sponsoring clinical trial NCT00001523?

This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00001523, the US trial registry maintained by the National Library of Medicine. NCT00001523 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.