None listed
Conditions
Brief summary
This study aims to evaluate the performance of 68Ga-Pentixafor positron emission tomography (PET) imaging in a cohort of newly diagnosed and relapsed myeloma patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma. Study details All participants in this study will undergo pentixafor-PET imaging and simultaneous whole-body magnetic resonance imaging (MRI) in a single sitting. The PET scan is the investigational intervention while the MRI scan is the internal control/gold standard. A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid thigh. The scan time for the 68Ga-Pentixafor PET/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally. Participants who have a positive PET will then be asked to undergo a second PET/MRI at the completion of their therapy. The scans will be interpreted using pre-specified criteria by investigators in the Department of Medical Imaging and Department of Nuclear Medicine at the Royal Brisbane Hospital. We will be examining a) the accuracy of pentixafor-PET compared with whole-body MRI for diagnosing myeloma bone lesions, b) the relationship between PET positivity and conventional disease prognostic markers, and c) the correlation between PET response and conventional biochemical response markers. It is hoped that PET imaging may offer complementary information about disease staging and prognosis, as seen in many other cancers including lymphoma and melanoma.
Interventions
All participants will undergo whole body MRI and 68Ga-Pentixafor PET (68Ga-CPCR4-2) at the Herston Imaging Research Facility (HIRF) at Time point 1 (Diagnosis: prior to, or within 2 weeks of commencing treatment). Participants who have a positive baseline PET will have a second PET/MRI at Timepoint 2 (Post-treatment; minimum 4 weeks/maximum 8 weeks following the cessation of treatment).
A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new
All participants will undergo whole body MRI and 68Ga-Pentixafor PET (68Ga-CPCR4-2) at the Herston Imaging Research Facility (HIRF) at Time point 1 (Diagnosis: prior to, or within 2 weeks of commencing treatment). Participants who have a positive baseline PET will have a second PET/MRI at Timepoint 2 (Post-treatment; minimum 4 weeks/maximum 8 weeks following the cessation of treatment). A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid thigh. The scan time for the 68Ga-Pentixafor PET/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally. Baseline demographic data will be collected at the time of written informed consent (Study Entry). Follow-up laboratory data will be obtained at Timepoints 1 and 2 by review of the participants’ medical records. Survival data will be collected at 3 monthly intervals by review of the patient medical record until progression, death or for 2 (two) years (whichever occurs earliest).
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria 1. Age >18 2. Able to give informed consent 3. Newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma
Exclusion criteria
Exclusion criteria 1. Females of child-bearing potential 2. Males who are unwilling to use an effective contraceptive method 3. Uncontrolled pain which precludes patient from lying supine 4. Patient-reported claustrophobia or anxiety which, in the opinion of the investigator, will prevent patient from completing the imaging procedures 5. Other contraindications to MRI according to institutional policy
Outcome results
None listed