Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI

NCT03132090 | Unknown DMC

• 1 other identifier: GK-MR/PET Tü-004
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Early therapy response assessment

  Early therapy response assessment by multiparametric hybrid imaging (PET/MRI) two weeks (early time point - study visit) and three months (regular staging) after therapy initiation with regard to optimizing patient management (please note: no therapy change intended based on the imaging at early time point (study visit t1)). Early study imaging data and later regular imaging data have to be compared.

  Baseline t0 (1st imaging / start of therapy), early therapy response (study visit) t1 (2 weeks after therapy start), regular therapy response (routine visit) t2 (3 month after therapy start)

Secondary Outcomes (2)

• prognostic capacity of morphological and functional MRI measures

  3 month

• prognostic value of PET/MRI-specific response

  18 month

Interventions

PET/MR (Biograph mMR) DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Dept. of Radiology, University of Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 32753543 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nina Schwenzer, MD

CONTACT

+49 7071 29-87720; nina.schwenzer@uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Nina Schwenzer (clinical professor & PI)

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 27, 2017
• Study Start: September 29, 2014
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)