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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253574
• Other study ID #: UBaselMM
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2020
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	University Hospital, Basel, Switzerland

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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