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Combined FDG PET/CT Imaging in Response Evaluation After Radiochemotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT01179360 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2017-11-17

No results posted yet for this study

Summary

To determine if combined \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 head and neck squamous cell carcinoma (HNSCC).

Primary study hypothesis: The lower bound of the 95% confidence interval (CI) of the negative predictive value (NPV) of FDG PET/CT to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.

Conditions

  • Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region

Interventions

OTHER

Integrated FDG PET/CT

Optimized PET/CT imaging with dedicated head-and-neck protocol

Sponsors & Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Sigrid Stroobants, MD, PhD · University Hospital, Antwerp

  • Laurens Carp, MD · University Hospital, Antwerp

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179360 on ClinicalTrials.gov