NCT00988936

Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug

A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Pilot Phase II Study The primary objective for this study is: * To explore the usefulness of \[F-18\]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed The secondary objectives for this study are: * To continue safety evaluation by collection of safety data from all patients * To gain experience with \[F-18\]RGD-K5 PET/CT in order to improve the study design and conduct of future studies Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of \[F-18\]RGD-K5 PET/CT (\~ 3-4 hrs) and the standard \[F-18\]FDG PET/CT (\~ 3-4 hrs) or diagnostic CT, followed by two \[F-18\]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard \[F-18\]FDG PET (\~ 3-4 hrs) or diagnostic CT. Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of \[F-18\]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally

Detailed description

The aim of this pilot study is to examine the utility of a new molecular imaging tracer, \[F-18\]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with Avastin® (Bevacizumab) plus standard chemotherapy. The changes of \[F-18\]RGD-K5 PET/CT image scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab) will be evaluated. The hypothesis for this study is that changes in the uptake of \[F-18\]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or angiogenesis. This pilot study will help to define if changes in uptake of \[F-18\]RGD-K5 are an early indicator of treatment efficacy to Avastin®.

Conditions

• Metastatic Breast Cancer
• Metastatic Colon/Rectum Cancer
• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	[F-18]RGD-K5	Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with \[F-18\]RGD-K5

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2009-10-02
• Last updated: 2012-08-22

Locations

8 sites across 1 country: United States