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

Completed

• Conditions: Malignant Melanoma
• Interventions: Diagnostic Test: Imaging with 18F-FDG PET/CT and/or Ultrasound

• Registration Number: NCT04253574
• Lead Sponsor: University of Basel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2017-09-01
• Study Completion: 2018-09-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-26
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with malignant melanoma	Imaging with 18F-FDG PET/CT and/or Ultrasound	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)).

Primary Outcome Measures

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