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

NCT ID: NCT01755650

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-11-03

Brief Summary

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

Detailed Description

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Conditions

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Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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D-18F FPM

Group Type EXPERIMENTAL

18F FPM

Intervention Type RADIATION

L-18F FPM

Group Type EXPERIMENTAL

18F FPM

Intervention Type RADIATION

Interventions

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18F FPM

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Solomon

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Locations

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Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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11/31

Identifier Type: -

Identifier Source: org_study_id

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