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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Melanoma
• Intervention / Treatment: Diagnostic test: Imaging with 18F-FDG PET/CT and/or Ultrasound

• Study Type: Observational
• Enrollment (Actual): 258

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

258 patients (112 (43%) women, 146 (57%) men, mean age: 61 ± 16 years)

Melanoma subtypes:

• nodular subtype (n = 68, 35% of the classified melanomas)
• superficial-spreading subtype (n = 61, 32%)
• acral lentiginous melanoma (n = 12, 6%)
• lentigo maligna (n = 7, 4%)
• rare subtypes (n = 44, 23%)
• melanoma without characterisation (n = 66)

At first diagnosis:

• 224 patients (87%) with a primary tumor only
• 34 patients (13%) with metastases only

Location of the melanoma lesion:

• head or neck: 48 patients
• trunk: 102 patients
• upper limbs: 42 patients
• lower limbs: 66 patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma	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.	September 1998 - August 2014

Collaborators and Investigators

• Sponsor: University of Basel
• Collaborators: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Joachim Hohmann, MD MSc, University of Basel

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Staging; Malignant Melanoma; 18F-FDG PET/CT
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: UBaselMM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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