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

A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755650

Enrollment

Registered

2012-12-24

Start date

2011-10-31

Completion date

2017-11-03

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma

Keywords

18F FPM, PET/CT, microdosing

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.

Interventions

RADIATION18F FPM

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026