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CompletedNCT00988936K5-101Updated Aug 22, 2012

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

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

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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®.

02

Conditions studied

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

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Keywords

  • [F-18]RGD-K5
  • RGD-K5
  • K5-101
  • Avastin
  • angiogenesis
  • anti-angiogenesis
  • chemotherapy
  • breast cancer
  • colon cancer
  • rectal cancer
  • lung cancer
  • non-squamous
  • non small cell
03

In context

Rectal Neoplasms

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 →

Lead sponsor

Siemens Molecular Imaging is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is >18 years and male or female of any race / ethnicity
  • Patient or patient's legally acceptable representative provides written informed consent and willing to comply with protocol requirements
  • Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by the treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
  • Patient will be scheduled to have a clinical [F-18]FDG-PET/CT or diagnostic CT pre-treatment after the fourth but before the fifth Avastin® treatment

Exclusion criteria

Exclusion Criteria:

  • Patient is not capable of complying with study procedures
  • Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:

    • Confirming in medical history that the patient is postmenopausal for a minimum of one year, or surgically sterile
    • Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
    • Confirming a negative urine dipstick test taken the morning of receiving the [F-18]RGD-K5
  • 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:

    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
    • Serum creatinine ≤ 2x institutional upper limits of normal
    • BUN within 2x institutional upper limits of normal
    • Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: Platelet counts of \< 75 x 103/μL
  • Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies
  • Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
  • Patient will participate in experimental therapy procedures while participating in this clinical trial
  • Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    [F-18]RDG-K5

    Drug: [F-18]RGD-K5

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

8 sites
  • University of California, Irvine
    Irvine, California 92697-5020, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • UMDNJ
    Newark, New Jersey 07103, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Hospital of University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Eastern Regional Medical Center
    Philadelphia, Pennsylvania 19124, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00988936
Lead sponsor
Siemens Molecular Imaging
Responsible party
Sponsor
First posted
Oct 2, 2009
Start date
Sep 2009
Primary completion
Mar 2012
Completion
May 2012
Last update
Aug 22, 2012

Study contacts

Edward Aten, MD
study director · President, Certus International

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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