mycosis fungiodes MedDRA version: 20.0 Level: PT Classification code 10028483 Term: Mycosis fungoides System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [1-13C]Pyruvate
Product Code: [1-13C]Pyruvate
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Sponsors
Dept.Dermotology , Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Patients diagnosed with MF, untreated or in stable dose systemic treatment for at least 2 months and no topical treatment (topical steroids, nitrogen mustard or UV treatment) for at least 14 days. • At least 18 years of age. • Adequate hematologic and organ function, i.e. • ANC at least 1.500/uL • Platlet count >100/uL • Se bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Contraindications to contrast enhanced MRI • Not able or willing to receive the treatment • Patients not willing to participate • Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events • Intolerant to Pyruvate • Pregnancy • Predicted remaining survival <3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of concept study for application of hyperpolarized [1-13C]Pyruvate in magnetic resonance spectroscopy for early detection of therapeutic effects in treatment of mycisis fugoides.;Secondary Objective: to test whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies for of treatment effects in skin cancers. ;Primary end point(s): The study will include 20 patients with MF treated at Department of Dermatology, Aarhus University Hospital. The first up to 10 patients in the study will be used for optimization of the technique (scanning parameter settings an coil selection: either 13C/21Na coil with 10x10 cm FOW or 13C/1H coil with 5x5 cm FOW). If sufficient signals can be obtained, the study will move on and include further 10 patients, who will be scanned 3 times, before treatment (day 0), day 8 and day 21 after initiation of treatment. Scanning’s of anatomical sites for each patient include the selected target MF skin lesion and non-lesional skin. Moreover, 5 patients with psoriasis and 5 healthy volunteers will be scanned once. The study will end after completing the above given exams. ;Timepoint(s) of evaluation of this end point: Milestones: a) if metabolic data form the first patients examined for adjusting the system do show too low signal to noise level the program will be canceled b) if the first metabolic data (before treatment) from MF patients are not different from the findings in patients with psoriasis the aim of the program shifts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): if metabolic data form the first patients examined for adjusting the system do show too low signal to noise level the program will be canceled ;Timepoint(s) of evaluation of this end point: after the first 10 MF patients | — |
Countries
Denmark
Contacts
Public ContactMR-Centre, Dept. Clinical Medicine,
MR-centre, Dept. Clinical Medicine, Aarhus University
Outcome results
None listed