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OpenTrials
Completed

NCT Number: NCT04253574

Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma

This is the first study which evaluates the different staging modalities 18F-2-fluoro-2-deoxy-D-glucose PET/CT (PET/CT) and diagnostic ultrasound (US) in a single patient cohort with malignant melanoma (MM). Previous analyses are ambivalent regarding the modality of choice. These analyses, however, compared separate patient cohorts for each modality.

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the existence of malignant melanoma (MM) as primary tumour or metastases

Exclusion criteria

  • the non-existence of a malignancy,
  • a malignancy other than MM, alone or in combination with an MM

Treatment and study plan

Imaging with 18F-FDG PET/CT and/or Ultrasound

Diagnostic Test

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.

Primary outcomes

  1. Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma

    Time frame: September 1998 - August 2014

    The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). 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.

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Official study title

Comparison of 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT and Ultrasound in Staging of Patients With Malignant Melanoma: An Analysis in a Single Patient Population

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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