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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013925

Enrollment

Registered

2018-01-29

Start date

2014-09-29

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C43.9

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
-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.	—

Measure

Time frame

-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.

—

Countries

Germany

Contacts

Public ContactThomas Eigentler

Universitätsklinikum Tübingen, Hautklinik, Sektion für Dermatologische Onkologie

thomas.eigentler@med.uni-tuebingen.de07071-29-85748

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026