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NCT01755650 Clinical Trial

Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies

Squamous Cell Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01755650
Other study ID # 11/31
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date October 2011
Est. completion date November 3, 2017

Study information
Verified date September 2023
Source Peter MacCallum Cancer Centre, Australia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date November 3, 2017
Est. primary completion date November 3, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• 18F FPM

Locations
Country Name City State
Australia Peter MacCallum Cancer Centre East Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest. 10, 30, 60 and 120 minutes post 18F FPM administration
Secondary Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration. 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Secondary 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 10, 30, 60 and 120 minutes post 18F FPM administration
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