Clinical trial NCT03132090: Early Therapy Response Monitoring in Melanoma Patients Using PET/MRI
Official title: Early Response Monitoring of Systemic Therapies in Patients With Advanced Melanoma by Simultaneous Positron-emission-tomography (PET)/Magnetic Resonance Imaging (MRI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Melanoma Stage IV
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Early therapy response assessment
timeFrame: 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:
measure: prognostic capacity of morphological and functional MRI measures
timeFrame: 3 month
measure: prognostic value of PET/MRI-specific response
timeFrame: 18 month
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Dept. of Radiology, University of Tuebingen
Study officials:
References:
citation: 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.