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

Peter MacCallum Cancer Centre, Australia

Status and phase: Terminated; Early Phase 1

Conditions: Squamous Cell Carcinoma

Treatments: Radiation: 18F FPM

Study type: Interventional

Funder types: Other

Identifiers

NCT01755650

11/31

Details and patient eligibility

About

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

D-18F FPM

Experimental group

Treatment:

Radiation: 18F FPM

L-18F FPM

Experimental group

Treatment:

Radiation: 18F FPM