Clinical trial NCT04253574: Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Keywords: Malignant Melanoma
Staging
18F-FDG PET/CT
Ultrasound
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2020-02-05
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma
timeFrame: September 1998 - August 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Basel
name: Joachim Hohmann, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.