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Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03132090
Recruitment Status : Unknown
Verified April 2017 by Prof. Dr. Nina Schwenzer, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
Prof. Dr. Nina Schwenzer, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Stage IV Diagnostic Test: PET/MR (Biograph mMR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Response Monitoring of Systemic Therapies in Patients With Advanced Melanoma by Simultaneous Positron-emission-tomography (PET)/Magnetic Resonance Imaging (MRI)
Actual Study Start Date : September 29, 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Intervention Details:
  • Diagnostic Test: 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

Primary Outcome Measures :
  1. Early therapy response assessment [ Time Frame: 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) ]
    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.

Secondary Outcome Measures :
  1. prognostic capacity of morphological and functional MRI measures [ Time Frame: 3 month ]
    testing the prognostic capacity of morphological and functional MRI measures (diffusion, perfusion) for predicting the concordance of therapy response results two weeks and three months after treatment initiation

  2. prognostic value of PET/MRI-specific response [ Time Frame: 18 month ]
    validation of the significance and prognostic value of the defined PET/MRI-specific response evaluation criteria by correlation with TTP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03132090

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Contact: Nina Schwenzer, MD +49 7071 29-87720

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Dept. of Radiology, University of Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Christina Pfannenberg, MD    +49 7071 2982756   
Contact: Brigitte Gueckel    +49 7071 2981212   
Sponsors and Collaborators
University Hospital Tuebingen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Nina Schwenzer, Prof. Dr. med. Nina Schwenzer (clinical professor & PI), University Hospital Tuebingen Identifier: NCT03132090    
Other Study ID Numbers: GK-MR/PET Tü-004
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas