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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01755650




Registration number
NCT01755650
Ethics application status
Date submitted
16/12/2012
Date registered
24/12/2012
Date last updated
24/12/2012

Titles & IDs
Public title
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Scientific title
A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
Secondary ID [1] 0 0
11/31
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 18F FPM

Experimental: D-18F FPM -

Experimental: L-18F FPM -


Treatment: Other: 18F FPM


Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
Timepoint [1] 0 0
Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary outcome [1] 0 0
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Timepoint [1] 0 0
10, 30, 60 and 120 minutes post 18F FPM administration
Secondary outcome [2] 0 0
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Timepoint [2] 0 0
30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Secondary outcome [3] 0 0
Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
Timepoint [3] 0 0
10, 30, 60 and 120 minutes post 18F FPM administration

Eligibility
Key inclusion criteria
- Written informed consent obtained prior to any protocol-specific procedures

- Male and female patients with histologically confirmed squamous cell carcinoma

- At least one site of active malignancy, as demonstrated on the pre-study 18F FDG
PET/CT scan performed as part of routine clinical care

- Age >/= 18 years

- Life expectancy >/= 3 months

- ECOG Performance score of 0-2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breastfeeding females

- Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG
PET/CT scan until after the 18F FPM PET/CT scan

- Any serious medical condition which the investigator feels may interfere with the
procedures or evaluations of the study

- Patients unwilling or unable to comply with protocol or with a history of
non-compliance or inability to grant informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Cooperative Research Centre for Biomedical Imaging Development
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the safety and potential effectiveness of the
imaging compound 18F FPM for finding sites of malignancies.
Trial website
https://clinicaltrials.gov/show/NCT01755650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Solomon
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sonia Mailer
Address 0 0
Country 0 0
Phone 0 0
61 3 9467 6277
Fax 0 0
Email 0 0
sonia.mailer@crcbid.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01755650