Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Melanoma Stage IV | Diagnostic Test: PET/MR (Biograph mMR) | Not Applicable |
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 |

- 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
- 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.
- 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
- 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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT03132090
Contact: Nina Schwenzer, MD | +49 7071 29-87720 | nina.schwenzer@uni-tuebingen.de |
Germany | |
Dept. of Radiology, University of Tuebingen | Recruiting |
Tuebingen, Germany, 72076 | |
Contact: Christina Pfannenberg, MD +49 7071 2982756 christina.pfannenberg@med.uni-tuebingen.de | |
Contact: Brigitte Gueckel +49 7071 2981212 brigitte.gueckel@med.uni-tuebingen.de |
Responsible Party: | Prof. Dr. Nina Schwenzer, Prof. Dr. med. Nina Schwenzer (clinical professor & PI), University Hospital Tuebingen |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |