Early evaluation of therapy response (targeted therapy and immunotherapy) in patients with metastasized malignant melanoma by multiparametric PET/MR imaging.

Not Applicable

• Conditions: C43.9; Malignant melanoma of skin, unspecified

• Registration Number: DRKS00013925
• Lead Sponsor: niversitätsklinikum Tübingen, Radiologische Klinik, Diagnostische & Interventionelle Radiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2017-08-22
• Study Start: 2018-01-29
• Study Completion: 2019-09-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Patient with diagnosed unresectable malignant melanoma stage IV,
-Age: =18 years,
-Planned systemic therapy with new therapies: BRAF/MEK inhibitors, Anti-CTLA-4/Anti-PD-1 antibodies,
-Clinically indicated routine PET/CT (baseline t0) demonstrating at least one measurable lesion,
-PET/CT for baseline-staging and therapy monitoring (clinical indication required),
-Informed consent.

Exclusion Criteria

-Contraindications for MR-imaging (metal implants, claustrophobia, etc.),
-Contraindications for gadolinium-based contrast agent,
-Acute infections or other acute diseases,
-Pregnant or breast-feeding women,
-Disability for informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of patient's treatment response rate as assessed by PET/MRI acquired two weeks and three months after therapy initiation using standard response criteria (RECIST, PERCIST).

Secondary Outcome Measures

Name	Time	Method
-Testing the prognostic capacity of morphological and functional MR measures (diffusion, perfusion) for predicting the concordance of therapy response results two weeks and three months after treatment initiation.<br>-Definition of PET/MRI-specific criteria for therapy response evaluation with respect to the personalized treatment approach, e.g. mode of action of biologicals” (kinase inhibitor and therapeutical antibodies).<br>-Validation of the significance and prognostic value of the defined PET/MRI-specific response evaluation criteria by correlation with TTP and OS.<br>