A Pilot, Open-label Study of 18F-Fluciclatide PET/CT Imaging in the Evaluation of Anti-angiogenic Therapy in Solid Tumors

Summary

Background:

* Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which preferentially binds with high affinity to alpha(v)beta(3) integrins, which are up-regulated in and may regulate angiogenesis.
* \[18F\]Fluciclatide is a new radiopharmaceutical developed for PET imaging
* Changes in \[18F\]fluciclatide uptake will be evaluated before and after treatment of patients with targeted antiangiogenic drugs

Objectives:

Primary

* To determine tumor uptake and retention of \[18F\]fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy
* Secondary
* To assess the safety of multiple intravenous (IV) administrations of Fluciclatide \[18F\] Injection in subjects with solid tumors
* To obtain preliminary data on the relationships between \[18F\]fluciclatide as a pharmacodynamic marker and standard of care imaging markers of clinical response (e.g. contrast-enhanced (CE) static computed tomography (CT), bone scintigraphy, FDG-PET), obtained as part of routine clinical follow-up as specified in the referring protocols, as well as any optional imaging performed

Eligibility:

* Patients greater than or equal to 18 years, with documented malignancy, and solid tumor greater than or equal to 1 cm outside of the liver, who are scheduled to enroll in an NCI therapy protocol using one of the anti-angiogenic agents described in the full protocol
* Platelet count greater than 75,000 x 10(6)/L, hemoglobin greater than 9g/dL, prothrombin time (PT) and aPTT less than 2 times normal limits.
* The subject has not received any targeted anti-angiogenic agents within 60 days prior to pre-treatment (baseline) \[18F\]fluciclatide administration

Design:

This study is intended to obtain preliminary data on the uptake and retention of \[18F\]fluciclatide before and after anti-angiogenic therapy. This will enable optimization of the imaging protocol, identification of the most relevant imaging parameters, and allow for calculation of the number patients required to power a larger study to assess the utility of PET imaging with \[18F\]fluciclatide as a pharmacodynamic biomarker in the context of targeted anti-angiogenic therapies. We expect to enroll 30 evaluable patients in this single center study. Subjects will undergo at least two \[18F\]fluciclatide PET/CT imaging studies, one pre-therapy and one following completion of 1 cycle of chemotherapy. An optional early post-therapy (2-7 days post therapy commencement) \[18F\]fluciclatide PET/CT may be performed. The magnitude of \[18F\]fluciclatide uptake on the pre- and post- treatment PET/CT studies will be evaluated to determine if there is a measureable difference in uptake. Data from the subject's referring therapy protocol will be reviewed for up to one year. An optional DCE-MRI scans of the target lesion may also be performed.

Conditions

• Colon Cancer
• Lung Cancer
• Cervical Cancer
• Renal Cell Carcinoma
• Uterine Cancer

Interventions

DRUG

(18)Fluciclatide

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC)

  collaborator NIH

• GE Healthcare

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  lead NIH

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-28

Primary Completion

2011-11-18

Completion

2011-11-18

Countries

• United States

Study Locations