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Clinical Trial Details

Pilot study of 68Ga-Pentixafor positron emission tomography (PET) imaging in multiple myeloma

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Anticipated date of first participant enrolment8/05/2017

Anticipated date of last participant enrolment8/05/2017

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

Key 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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Royal Brisbane and Women's Hospital Metro North Hospital and Health Service Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12617000593336

Contact person for information and recruitmentDr
Nicholas Weber
Cancer Care Services Royal Brisbane and Women's Hospital Butterfield Street Herston QLD 4029
+61 7 3646 8111

Further information iconnicholas.weber@health.qld.gov.au
Australia