Positron Emission Tomography with AT-01 to Diagnose and Monitor Amyloidosis: A Prospective Cohort Pilot Study.

Not Applicable

Conditions: Amyloidosis
Blood - Haematological diseases
Cardiovascular - Other cardiovascular diseases
Metabolic and Endocrine - Other metabolic disorders
Neurological - Other neurological disorders
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12624000755538

Lead Sponsor: Metro South Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic amyloidosis [I124-AT-01 PET-CT imaging Baseline and between 6-12 months post initial scan];Diagnose the presence and extent of systemic amyloidosis organ involvement[Visual analysis of AT-01 radiotracer organ uptake compared to current standard International Society of Amyloidosis (ISA) criteria. Baseline scan at diagnosis];Determine if the change in organ specific amyloid burden using AT-01 PET/CT imaging, [Comparison of baseline and follow-up scan, correlates with consensus ISA organ response criteria. Baseline and 12 months post baseline scan,]

Secondary Outcome Measures

Name	Time	Method
Correlation between AT-01 PET/CT defined response or progression and standard amyloidosis response or progression definitions.[Change in AT-01 radiotracer uptake between baseline and repeat scans and ISA organ response criteria. Baseline and 12 months post baseline scan,];Adverse events and tolerability of AT-01 PET/CT imaging[Adverse event reporting through use of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. <br>To date mild adverse reactions using AT-01 in humans have been reported including chest discomfort, rhinorrhoea, puritis and nausea. No more than mild treatment emergent adverse events related AT-01 or ancillary Potassium Iodide administered alongside have been reported to date. From day of scan to 7 days post for both baseline and follow up scans. ]