None listed
Conditions
Brief summary
AT-01 is a novel peptide radiotracer which binds to a constant region of the insoluble amyloid protein; the agent which results in end-organ damage in AL amyloidosis. It is able to demonstrate on molecular imaging scans the presence of amyloid within all vital organs of the body, namely the heart, kidneys, liver and spleen. No other imaging modality has been able to capture this in a single scan. By accurately detecting amyloid in organs of the body and assessing for response to therapy, AT-01 PET/CT scans have the potential to revolutionise the way AL amyloidosis is diagnosed, monitored, and help to guide treatment decisions in the future.
Interventions
If participants enrol in the study they will undergo PET-CT imaging with AT-01 to assess if it is able to diagnose organ involvement of systemic amyloidosis and give an indication of systemic amyloid burden. 2 scans will be performed; initially at diagnosis and repeated after 6-12 months post standard of care treatment.
Participants will consent to having two additional scans performed in addition to their usual standard of care and to de-identified data collection.
Females of childbearing ag
If participants enrol in the study they will undergo PET-CT imaging with AT-01 to assess if it is able to diagnose organ involvement of systemic amyloidosis and give an indication of systemic amyloid burden. 2 scans will be performed; initially at diagnosis and repeated after 6-12 months post standard of care treatment. Participants will consent to having two additional scans performed in addition to their usual standard of care and to de-identified data collection. Females of childbearing age will need to undergo pregnancy screening (urine or blood) within 72 hours of each scan. Imaging will be performed within the nuclear medicine department of the respective hospitals under the care of an experienced nuclear physician team. The compound will be diluted with 10ml of saline and administered via IV push method at a rate of 1ml/5 seconds. The exact time of calibration of the dose will be recorded using a global time piece consistently used throughout the study for time recording (internet time). The exact start time of infusions/injections are to be noted and recorded to permit correction of the administered dose for radioactive decay. The dose calibrator and PET/CT scanner clocks will be synchronized. Image acquisition starts 5 hours post tracer administration. A Low dose CT scan for attenuation correction and co-registration will be performed. Imaging will include vertex to mid-thigh, scan in the caudal-cranial direction. Five minutes per bed position will be used with the exception of the bed position over the heart which will be acquired for ten minutes resulting in a scan that lasts 45 minutes in total. Subject will lay supine with arms by their sides for imaging.
Sponsors
Metro South Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of amyloidosis with the known following subtype: (a) Systemic AL amyloidosis prior to therapy commencement (n=15) (b) Systemic AL amyloidosis with suboptimal response to therapy or in early biochemical relapse (n=5) (c) ATTRwt amyloidosis (n=5) (d) Other systemic amyloidosis i.e. ALECT2 and Alys amyloidosis (n=5) 2. Age equal to or greater than 18yrs 3. Life expectancy greater than 3 months
Exclusion criteria
1. Localised amyloidosis 2. Known iodine or potassium iodide hypersensitivity 3. Patients being treated with heparin and heparin like anticoagulant therapy (due to interaction with AT-01) 4. Patients who are pregnant and/or breastfeeding
Outcome results
None listed