An interventional study of PET/MR (Biograph mMR) in Malignant Melanoma Stage IV, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-27.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Diagnostic
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.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 106 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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
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.
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)
prognostic capacity of morphological and functional MRI measures
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
Time frame: 3 month
prognostic value of PET/MRI-specific response
validation of the significance and prognostic value of the defined PET/MRI-specific response evaluation criteria by correlation with TTP
Time frame: 18 month
Plan to share: No
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen