Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
NCT ID: NCT04253574
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
258 participants
OBSERVATIONAL
2014-09-01
2018-09-01
Brief Summary
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Inclusion criteria were a primary staging or re-staging of suspected or confirmed MM with one or more PET/CT and/or one or more US. Exclusion criteria were the non-existence of a malignancy or a malignancy other than MM, alone or in combination with an MM.
The analysis includes the calculation of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). This was done individually for PET/CT and US, and in PLA also for the combination of these two radiological modalities. Furthermore, US was divided into US as a whole (wUS), peripheral lymph nodes (pUS) and/or abdomen (aUS).
The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in all three analyses. As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Patients with malignant melanoma
258 patients (w: 112, m: 146 age: 61±16 years) met the primary inclusion criteria. They were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)).
Imaging with 18F-FDG PET/CT and/or Ultrasound
All patients were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)) in the search of primary tumors or metastases of their malignant melanomas.
Interventions
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Imaging with 18F-FDG PET/CT and/or Ultrasound
All patients were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)) in the search of primary tumors or metastases of their malignant melanomas.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* a malignancy other than MM, alone or in combination with an MM
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
University of Basel
OTHER
Responsible Party
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Joachim Hohmann
Associate Professor
Principal Investigators
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Joachim Hohmann, MD MSc
Role: PRINCIPAL_INVESTIGATOR
University of Basel
References
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Xing Y, Bronstein Y, Ross MI, Askew RL, Lee JE, Gershenwald JE, Royal R, Cormier JN. Contemporary diagnostic imaging modalities for the staging and surveillance of melanoma patients: a meta-analysis. J Natl Cancer Inst. 2011 Jan 19;103(2):129-42. doi: 10.1093/jnci/djq455. Epub 2010 Nov 16.
Related Links
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Independent Institute for Quality and Efficiency in Health Care (IQWiG) final report on MM staging \[German\]
Other Identifiers
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UBaselMM
Identifier Type: -
Identifier Source: org_study_id
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