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

• Sponsor: University of Basel (Other)
• Overall Status: Completed
• CT.gov ID: NCT04253574
• Collaborator: University Hospital, Basel, Switzerland (Other)
• Enrollment: 258
• Actual Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma	Diagnostic Test: Imaging with 18F-FDG PET/CT and/or Ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 258 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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)).	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Basel
• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Joachim Hohmann, MD MSc, University of Basel

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Independent Institute for Quality and Efficiency in Health Care (IQWiG) final report on MM staging [German]

Publications

• 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.

• Responsible Party: Joachim Hohmann, Associate Professor, University of Basel
• ClinicalTrials.gov Identifier: NCT04253574
• Other Study ID Numbers: UBaselMM
• First Posted: Feb 5, 2020
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Joachim Hohmann, Associate Professor, University of Basel: Malignant Melanoma; Staging; 18F-FDG PET/CT; Ultrasound
• Additional relevant MeSH terms: Melanoma; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Feb 5, 2020