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NCT03342378 · ClinicalTrials.gov registry record
PET-MRI Assessment of Early Tumor Response to Predict Outcomes of HPV-Positive Oropharynx Cancer Patients
A clinical trial of Squamous Cell Carcinoma and Oropharynx Cancer, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 24
- Enrollment target
- 1
- Study location
NCT03342378 is a study of Squamous Cell Carcinoma and Oropharynx Cancer that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 24 participants, below the 104-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03342378, a study of Squamous Cell Carcinoma and Oropharynx Cancer, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This proposal explores the novel hypothesis that the variability in outcomes within the Intermediate Risk(IR) HPV-positive Oropharynx Squamous Cell Carcinoma(OPSCC) cohort can be exploited to identify a subpopulation that exhibits outcomes similar to Low Risk (LR) HPV-positive Oropharynx Squamous Cell Carcinoma and therefore would be appropriate candidates for radiation dose de-escalation approaches. Current literature using PET, CT, and MRI as single imaging modalities have identified certain criteria within heterogenous patient populations that are associated with clinical outcomes. Here, the investigators will test the hypothesis that multiparametric analysis of simultaneously-acquired MRI and PET quantitative imaging biomarker data from the primary tumor prior to initiating therapy, after 2 weeks of chemoradiation(CRT), and 3 months following completion of chemoradiation in patients with Intermediate Risk HPV-positive Oropharynx Squamous Cell Carcinoma will generate parametric maps that are predictive of clinical outcome. Furthermore, the investigators will collect blood samples prior to, during, and after radiation therapy to evaluate whether levels of detected circulating tumor cells correlate with response to treatment.
Conditions Studied
Interventions
- RADIATION Intensity modulated radiotherapy (IMRT)
- DIAGNOSTIC_TEST PET-MRI
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2021-05-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03342378
The ClinicalTrials.gov registry entry for NCT03342378 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (77% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Intensity modulated radiotherapy (IMRT) is the first listed.
NCT03342378 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03342378 about?
NCT03342378 is a clinical study titled "PET-MRI Assessment of Early Tumor Response to Predict Outcomes of HPV-Positive Oropharynx Cancer Patients". This proposal explores the novel hypothesis that the variability in outcomes within the Intermediate Risk(IR) HPV-positive Oropharynx Squamous Cell Carcinoma(OPSCC) cohort can be exploited to identify a subpopulation that exhibits outcomes similar to Low Risk (LR) HPV-positive Oropharynx Squamous Ce...
What is the current status of trial NCT03342378?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2018-05-03. Estimated completion is 2021-05-15.
What conditions does trial NCT03342378 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Oropharynx Cancer.
What interventions are being tested in trial NCT03342378?
The interventions under investigation include: Intensity modulated radiotherapy (IMRT) (RADIATION), PET-MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03342378?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03342378 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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