Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI

NCT ID: NCT03132090

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-29
• Study Completion Date: 2018-06-30

Brief Summary

Therapeutic agents used in malignant melanoma treatment such as BRAF/MEK inhibitors and anti-CTLA-4/Anti-PD-1 antibodies go along with harmful side effects in a considerable proportion of patients and treatment costs may cause relevant medical expenditures per month. Currently, therapy response assessment in melanoma patients is performed using RECIST criteria which are based on changes in tumour size. PET/CT combines morphological and metabolic information. Thus, the so-called PERCIST-criteria were introduced integrating change in size and glucose utilization for response assessment in solid tumors. Due to the different mechanism of action these new agents introduce different response patterns increase in tumor size due to inflammation for antibody therapies). In conventional chemotherapies, re-staging is usually performed 3 months after treatment initiation which is the result of empirical investigations. Moreover, it has recently been shown, that response to new targeted therapies can be detected much earlier using PET or functional MR techniques. This forms the rationale for the monitoring of melanoma patients using a combined PET/MR technique after only 2 weeks of therapy initiation. Especially for patients in stage IV with a medium survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have significant consequences for the individual clinical course.

Conditions

Malignant Melanoma Stage IV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

PET/MR (Biograph mMR)

The combination of PET and MRI allows for evaluation of metabolic, functional and morphological parameters such as glucose metabolism, perfusion, diffusion restriction or size in one examination. Due to the combination of MRI and PET in one scanner it is possible to align the acquired PET and MR datasets with high precision

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• patient with diagnosed unresectable malignant melanoma stage IV
• age: ≥18 years
• planned systemic therapy with either new therapies (BRAF/MEK inhibitors, Anti-CTLA-4/Anti-PD-1 antibodies) or conventional chemotherapeutics (CTx)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Nina Schwenzer

Prof. Dr. med. Nina Schwenzer (clinical professor & PI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept. of Radiology, University of Tuebingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nina Schwenzer, MD

Role: CONTACT

nina.schwenzer@uni-tuebingen.de

+49 7071 29-87720

Facility Contacts

Christina Pfannenberg, MD

Role: primary

christina.pfannenberg@med.uni-tuebingen.de

+49 7071 2982756

Brigitte Gueckel

Role: backup

brigitte.gueckel@med.uni-tuebingen.de

+49 7071 2981212

References

Seith F, Forschner A, Weide B, Guckel B, Schwartz M, Schwenck J, Othman AE, Fenchel M, Garbe C, Nikolaou K, Schwenzer N, la Fougere C, Pfannenberg C. Is there a link between very early changes of primary and secondary lymphoid organs in 18F-FDG-PET/MRI and treatment response to checkpoint inhibitor therapy? J Immunother Cancer. 2020 Aug;8(2):e000656. doi: 10.1136/jitc-2020-000656.

Reference Type: DERIVED

PMID: 32753543 (View on PubMed)

Other Identifiers

GK-MR/PET Tü-004

Identifier Type: -

Identifier Source: org_study_id