Back to resultsPhase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Primary Purpose
Squamous Cell Carcinoma
Status
Terminated
Phase
Early Phase 1
Locations
Australia
Study Type
Interventional
Intervention
18F FPM
Sponsored by
About this trial
This is an interventional diagnostic trial for Squamous Cell Carcinoma focused on measuring 18F FPM, PET/CT, microdosing
Eligibility Criteria
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
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
Sites / Locations
- Peter MacCallum Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
D-18F FPM
L-18F FPM
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
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
Full Information
NCT ID
NCT01755650
First Posted
December 16, 2012
Last Updated
September 8, 2023
Sponsor
Peter MacCallum Cancer Centre, Australia
1. Study Identification
Unique Protocol Identification Number
NCT01755650
Brief Title
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Official Title
A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.
Study Start Date
October 2011 (Actual)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
18F FPM, PET/CT, microdosing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-18F FPM
Arm Type
Experimental
Arm Title
L-18F FPM
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
18F FPM
Primary Outcome Measure Information:
Title
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
Time Frame
Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary Outcome Measure Information:
Title
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Time Frame
10, 30, 60 and 120 minutes post 18F FPM administration
Title
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Time Frame
30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Title
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
Time Frame
10, 30, 60 and 120 minutes post 18F FPM administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Solomon
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
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