A Phase 2 interventional study of [F-18]RGD-K5 in Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer and Non-squamous Non-small Cell Lung Cancer, sponsored by Siemens Molecular Imaging. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-22.
Sponsored by Siemens Molecular Imaging · Phase 2 and Interventional
A Pilot Phase II Study
The primary objective for this study is:
The secondary objectives for this study are:
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
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®.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 35 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Siemens Molecular Imaging is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:
Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
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
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.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
To continue safety evaluation by collection of safety data from all patients.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Siemens Molecular Imaging