Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000401156
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
12/03/2019
Date last updated
25/04/2024
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MINERAL: Magnetic Resonance Imaging and Quantitative Susceptibility Mapping (MRI-QSM) of brain iron to identify Chemotherapy-Associated Neurocognitive Impairment (CANI) in Acute Myeloid Leukaemia (AML).
Scientific title
MINERAL: Magnetic Resonance Imaging and Quantitative Susceptibility Mapping (MRI-QSM) of brain iron to identify Chemotherapy-Associated Neurocognitive Impairment (CANI) in Acute Myeloid Leukaemia (AML).
Secondary ID [1] 297617 0
CT-2018-CTN-03575-1
Universal Trial Number (UTN)
Trial acronym
MINERAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia 311890 0
Condition category
Condition code
Cancer 310478 310478 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective observational longitudinal cohort study (pilot study).
Patients undergoing standard chemotherapy treatment will be eligible for participation in this study.
In addition to their standard management, participants will undergo observations at three time points to identify any potential signs of chemotherapy-associated neurocognitive impairment (CANI).
These observations include:
- Neurocognitive Assessment (NCA), in the form of a one-hour standardised interview with a clinical neuropsychologist (see below); and
- Magnetic resonance imaging with quantitative susceptibility mapping (MRI-QSM) brain imaging.
The observations will be performed at baseline, at completion of chemotherapy, and then again at 6 months following completion of all therapy.

The 1-hour standardised NCA will contain the following validated assessment tools:
1) Test of Premorbid Function (TOPF), which will provide an overall estimate of the participant’s overall intelligence level. Number of years of education will be documented.
2) Mini Mental State Examination (MMSE) will provide an indication of global cognitive functioning.
3) Cognition will be assessed using measures to evaluate motor speed (the Finger Tapping Test), auditory attention and working memory (Wechsler Memory Scale – Third Edition Digit Span), verbal learning and memory (Rey Auditory Verbal Learning Test) and aspects of executive functioning including mental flexibility (Trail Making Test) and verbal generativity (Controlled Oral Word Association Test (COWAT).
4) Psychological variables will be evaluated through self-report questionnaires canvasing anxiety and depression (Hospital Anxiety and Depression Scale), patient perception of quality of life – European Organisation for Research and Treatment of Cancer Quality of Life Scale (EORTC-QLQ-C30) and evaluation of subjective symptoms of fatigue (EORTC-QLQ-FA12).

An overall composite score will be tallied for the NCA at each Time Point.
Intervention code [1] 313855 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319343 0
Change in composite NCA Score between baseline and following completion of consolidation chemotherapy (based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
Timepoint [1] 319343 0
The primary outcome will be assessed following the completion of the final time point by the final study participant (ie when all study data has been collected).

It is expected that each participant will have completed all study assessments within 9-12 months.
Secondary outcome [1] 367845 0
1., Change in NCA Score between completion of consolidation chemotherapy and six-month follow-up (based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
Timepoint [1] 367845 0
All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.

It is expected that each participant will have completed all study assessments within 9-12 months.
Secondary outcome [2] 367925 0
2. Worst score in any NCA target area between baseline, completion of consolidation chemotherapy, and six-month follow-up.
(target areas detailed in Step 3; assessment performed based on one-hour interview with clinical neuropsychologist using methods detailed in Step 3)
Timepoint [2] 367925 0
All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.
Secondary outcome [3] 367926 0
3. Change in brain iron deposition pattern on MRI-QSM imaging between baseline, post consolidation chemotherapy, and six months’ follow-up
Timepoint [3] 367926 0
All outcomes will be after the assessed following the completion of the final time point (6 months post final treatment) for all participants.

Eligibility
Key inclusion criteria
Adults commencing induction chemotherapy for Acute Myeloid Leukaemia (AML).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical contraindications to MRI according to institutional policy;

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Patient and treatment characteristics and study outcomes will be described using mean, standard deviation and range or median, interquartile range and range for continuous variables, frequencies and percentages for categorical variables and the Kaplan-Meier method for time-to event variables. A mixed effect model will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/03/2019
Actual
22/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13314 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25904 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 302160 0
Charities/Societies/Foundations
Name [1] 302160 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 302160 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
c/o Dr Ashleigh Scott
Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 301997 0
None
Name [1] 301997 0
Address [1] 301997 0
Country [1] 301997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302841 0
Royal Brisbane and Women's Hospital EC00172
Ethics committee address [1] 302841 0
Butterfield St, Herston QLD 4029
Ethics committee country [1] 302841 0
Australia
Date submitted for ethics approval [1] 302841 0
21/09/2018
Approval date [1] 302841 0
16/11/2018
Ethics approval number [1] 302841 0
HREC/2018/QRBW/45522

Summary
Brief summary
This study seeks to detect chemotherapy-associated neurocognitive impairment in patients with Acute Myeloid Leukemia, using Neurocogntive Assessment and Magnetic Resonance Imaging.

Who is it for?
You may be eligible to join this study if you are aged 18 and above and are commencing induction chemotherapy for Acute Myeloid Leukaemia (AML).

Study details
This prospective longitudinal pilot study seeks to determine the prevalence and severity of chemotherapy-associated neurocognitive impairment (CANI) in patients undergoing treatment for AML, and to evaluate the feasibility of using magnetic resonance imaging as a biomarker of CANI in this population. Each participant will undergo Neurocognitive Assessment (NCA) and Magnetic Resonance Imaging Quantitative Susceptibility Mapping of brain iron (MRI-QSM) before and after their treatment for AML

It is hoped that the findings from this trial will provide information regarding the incidence of chemotherapy associated neurocognitive impairment during AML treatment, and the feasibility of using MRI-QSM as a diagnostic tool in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91574 0
Dr Ashleigh Scott
Address 91574 0
Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 91574 0
Australia
Phone 91574 0
+61736468111
Fax 91574 0
Email 91574 0
[email protected]
Contact person for public queries
Name 91575 0
Ashleigh Scott
Address 91575 0
Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 91575 0
Australia
Phone 91575 0
+61736468111
Fax 91575 0
Email 91575 0
[email protected]
Contact person for scientific queries
Name 91576 0
Ashleigh Scott
Address 91576 0
Level 5, Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 91576 0
Australia
Phone 91576 0
+61736468111
Fax 91576 0
Email 91576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
as per ethics approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.