Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
Public ClinicalTrials.gov record NCT00988936. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00988936
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2009 (Type not available)
- Primary completion
- Mar 2012 (Actual)
- Completion
- May 2012 (Actual)
- Last update posted
- Aug 22, 2012
2009 – 2012
United States locations
- U.S. sites
- 8
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697-5020 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| UMDNJ | Newark | New Jersey | 07103 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00988936, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2012 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00988936 live on ClinicalTrials.gov.