Reproducibility of 18F Uptake by Solid Tumors Using PET Imaging Following Intravenous Administration of (18F) Injection

NCT ID: NCT00918281

Last Updated: 2014-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-10-31

Brief Summary

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Study aimed to assess the reproducibility of PET imaging using AH111585 (18F) Injection. Subjects are evaluable if they undergo 2 administrations of AH111585 (18F) Injection (3 to 8 days apart) and the corresponding PET acquisitions, and tumors demonstrate detectable levels of 18F uptake on PET.

Detailed Description

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Conditions

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Solid Tumors High Grade Gliomas Lung Cancer Head and Neck Cancer Sarcoma Renal Cell Carcinoma Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluciclatide Injection

Fluciclatide Injection

Group Type EXPERIMENTAL

Fluciclatide Injection

Intervention Type DRUG

Fluciclatide Injection (AH111585 (18F) Injection)

Interventions

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Fluciclatide Injection

Fluciclatide Injection (AH111585 (18F) Injection)

Intervention Type DRUG

Other Intervention Names

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Fluciclatide AH111585 (18F) Injection

Eligibility Criteria

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Inclusion Criteria

* The subject has been diagnosed with at least one solid primary or metastatic tumor greater than 2.0 cm in diameter, including but not limited to NSCLC, RCC, GBM, melanoma, sarcoma, breast and H\&N cancers.
* The subject has received clinical routine imaging diagnostic work-up within 8 weeks prior to the first \[18F\]AH111585 PET scan.
* The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care.

Exclusion Criteria

* The subject has known hyper- or hypo-coagulation syndromes.
* The subject has received chemotherapy within 3 weeks, or received radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to the first \[18F\]AH111585 PET scan.
* The subject is scheduled to undergo chemotherapy, radiotherapy, surgery or any other treatment against cancer between the first and second \[18F\]AH111585 PET scans.
* The subject is scheduled to undergo biopsy for the target tumour between the first and second \[18F\]AH111585 PET scans.
* The subject has intra-hepatic tumour(s) only.
* For the immuno-histochemistry group, the subject's target tumour has been biopsied less than or equal to 1 week prior to the first \[18F\]AH111585 PET scan.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BIAFFIN GmbH & Co. KG (Biomolecular Interaction Analyses)

UNKNOWN

Sponsor Role collaborator

Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

i3 Statprobe

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Winick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

GE Healthcare

Locations

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101 Carnegie Center

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GE-135-004

Identifier Type: -

Identifier Source: org_study_id

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