Upper/lower respiratory tract bacterial infections or orthopaedic bacterial infections
Conditions
Interventions
Product Name: [68Ga]Ga-Deferoxamine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DEFEROXAMINE MESILATE
CAS Number: 138-14-7
Current Sponsor code: deferoxamine
Other descriptive nam
Desferal
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: [68Ga]Ga DEFEROXAMINE
CAS Number: 70-51-9
Current Sponsor code: [68Ga]Ga-Deferoxa
Sponsors
Medizinische Universität Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures. 2 Age > 18 years. 3 Patients with bacterial infections (e.g. Pseudomonas aeruginosa, Staphylococcus spp., Streptococcus spp., etc. of any region except the urinary tract) or patients with infections of implanted devices (e.g. orthopaedic or vascular implants, pacemakers, catheters, etc.). 4 Strong clinical indication or confirmation of bacterial infection with typical alterations of laboratory markers (ESR, CRP, and/or leucocyte number). If microbiologically confirmed, the bacterial spectrum must be available. If not microbiologically confirmed, any available microbiology samples before antibiotic treatment should be stored for following studies on [68Ga]Ga-Deferoxamine uptake in vitro. 5 Participating men must use a single barrier method for contraception for 1 month after completion of the trial starting at the day of application of [68Ga]Ga–Desferoxamine. 6 Women of childbearing age must use two highly effective methods of contraception during the trial and 6 months after application of investigational product if not in menopause or after hysterectomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1 Pregnancy; breast-feeding; females planning to bear a child recently or with childbearing potential, unless a commonly accepted effective means of contraception is used. 2 Patients with cystic fibrosis (CF) 3 Patients having a confirmed bacterial infection with a bacterial spectrum that is known to lack uptake of [68Ga]Ga-Deferoxamine (e.g. E.coli) 4 Patients under therapy with Deferoxamine (Desferal®) or other metal chelators. 5 Patients with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease). 6 Any other concurrent severe and/or uncontrolled and/or unstable medical condition that, in the opinion of the investigator, may significantly interfere with study compliance. 7 Known or expected hypersensitivity to Ga-68 or Deferoxamine (Desferal®). 8 Prior administration of a radiopharmaceutical for PET-imaging within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical. 9 Subjects with any kind of dependency on the investigator or are employed by the sponsor or investigator. 10 Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease. 11 History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. 12 Patients with iron overload disease. 13 Patients with glomerular filtration rate below 30 ml/min/1,73 m2 where primarily renal excretion of Ga-68 or Deferoxamine could be impaired.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: 1.Safety and tolerability [68Ga]Ga-Deferoxamine in human subjects 2.Preliminary diagnostic sensitivity of [68Ga]Ga-Deferoxamine ;Secondary Objective: Secondary objectives: 1.Radiation dosimetry of [68Ga]Ga-Deferoxamine in human subjects 2.To characterise the pharmacokinetics of [68Ga]Ga-Deferoxamine in human subjects;Primary end point(s): Primary Endpoints: 1.Number of participants with adverse events as a measure of safety and tolerability after [68Ga]Ga-Deferoxamine injection and PET/CT scanning, as per CTCAE (v5.0). 2.Diagnostic sensitivity of [68Ga]Ga-Deferoxamine defined as quantitative measurement of standardised uptake values (SUVs) of bacterial lesions. ;Timepoint(s) of evaluation of this end point: Completion of 15 patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: 1. Radiation dosimetry of [68Ga]Ga-Deferoxamine in human: estimation of the organ absorbed doses and effective dose from [68Ga]Ga-Deferoxamine PET/CT scan. 2. Pharmacokinetic calculations: Quantification of urinary excretion and half-life in blood of [68Ga]Ga-Deferoxamine 3. Description of [68Ga]Ga-Deferoxamine accumulation in bacterial lesions (number of lesions, SUV value per lesion).;Timepoint(s) of evaluation of this end point: Secondary Endpoint 1 and 2: Completion of 4 patients Secondary Endpoint 3: Completion of all 15 patients | — |
Countries
Austria
Contacts
Public ContactChefsekretariat
Universitätsklinik für Nuklearmedizin
Outcome results
None listed