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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: Completed study of Squamous Cell Carcinoma and Oropharynx Cancer, sponsored by University of Wisconsin, Madison.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Patients with LR and IR HPV-positive OPSCC will be segregated into favorable and unfavourable cohorts using radiographic change(MRI/PET) in the primary tumor between pre-treatment and intra-treatment. T-stage, N-stage, and pack-years smoking markers will be used as surrogate markers

Interventions

  • RADIATION Intensity modulated radiotherapy (IMRT)
  • DIAGNOSTIC_TEST PET-MRI

Study Locations (1)

Wisconsin

  • University of Wisconsin Carbone Cancer Center - Madison

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-05-03
Est. Completion 2021-05-15
University of Wisconsin, Madison

1,039 total trials

What the finished NCT03342378 record still lists

NCT03342378 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 104-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (77% lower).

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 a single indexed study location in 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.

Similar trials for Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03342378's enrollment target sits among peer trials

24 39th of 47 higher than 9 of 47 other Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03342378, the US trial registry maintained by the National Library of Medicine. NCT03342378 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.