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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013925
• Date of registration: 29/01/2018
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Tübingen, Radiologische Klinik, Diagnostische & Interventionelle Radiologie
• Public title: Early evaluation of therapy response (targeted therapy and immunotherapy) in patients with metastasized malignant melanoma by multiparametric PET/MR imaging.
• Scientific title: Early evaluation of therapy response (targeted therapy and immunotherapy) in patients with metastasized malignant melanoma by multiparametric PET/MR imaging. - GK-MR/PET Tü-004
• Date of first enrolment: 29/09/2014
• Target sample size: 70
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00013925
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: diagnostic
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Ferdinand Seith
• Affiliation: Universitätsklinikum Tübingen, Radiologische Klinik, Diagnostische & Interventionelle Radiologie

• Name: Thomas Eigentler
• Affiliation: Universitätsklinikum Tübingen, Hautklinik, Sektion für Dermatologische Onkologie

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malignant melanoma of skin, unspecified

C43.9

C43.9

Intervention(s)

Group 1: PET/MR examination of melanoma patients (Stage IV) at timepoints of therapy initiation (t0), as well as 2 weeks (t1) and 12 weeks (t2) after therapy start.

Primary Outcome(s)

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(s)

-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.
-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).
-Validation of the significance and prognostic value of the defined PET/MRI-specific response evaluation criteria by correlation with TTP and OS.

Source(s) of Monetary Support

Universitätsklinikum Tübingen

Wilhelm Sander Stiftung

Ethics review

Status: Approved
Approval date: 23/08/2012
Contact:

[e-mail]

Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 03/08/2018
• Date Completed: 03/09/2019
• URL: http://drks.de/search/en/trial/DRKS00013925#studyResults