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Status:

WITHDRAWN

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

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

National Institutes of Health Clinical Center (CC)

GE Healthcare

Conditions:

Colon Cancer

Lung Cancer

Eligibility:

All Genders

18-100 years

Phase:

PHASE1

PHASE2

Brief 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 regu...

Detailed Description

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 regu...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Adult subjects (greater than or equal to18 years old), with documented malignancy, with at least one solid tumor greater than or equal to 1 cm in diameter (not within the liver), who are scheduled to enroll in an NCI therapy protocol using one of the anti-angiogenic therapy agents (Vandetanib, Cediranib or Bevacizumab)
  • The subject has a platelet count of 150,000 x 10(6)/L, hemoglobin value of greater than 9 g/dL, PT and an aPTT less than 2 times normal limits.
  • The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from less than 4 weeks before administration of Fluciclatide (18F) Injection); i.e. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  • The subject has had no open surgical wounds in close proximity to the target lesion(s) within 10 days prior to study entry.
  • The subject has not had a biopsy of the target lesion within 7 days of PET/CT imaging.
  • The subject has not had radiation therapy to the region of the target lesion.
  • Enrolling in the following NCI anti-angiogenic therapy protocols:
  • 08-C-0020
  • 09-C-0192
  • 07-C-0058
  • 09-C-0019
  • EXCLUSION CRITERIA:
  • The subject is pregnant or lactating.
  • The subject is being treated with doses of heparin or warfarin resulting in elevation of PT or aPTT greater than 2 times normal.
  • The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib, sunitinib) within 60 days prior to pre-treatment (baseline) \[18F\]fluciclatide PET imaging. This stipulation does not apply after the baseline \[18F\]fluciclatide PET imaging.
  • The subject has received another investigational medicinal product (IMP) within 24 hours before or is scheduled to receive another IMP within 24 hours after Fluciclatide (18F) Injection.
  • The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).
  • The subject is unable to lie still for 75 minutes.
  • The subject is known to have a history of hyper- or hypo-coagulation syndromes resulting in prolongation of bleeding parameters. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.
  • The subject has undergone a surgical procedure to the target lesion within 28 days prior to baseline \[18F\]fluciclatide administration OR is scheduled to undergo a surgical procedure between the baseline and post 1-cycle \[18F\]fluciclatide PET/CT.
  • The subject has only bone metastasis
  • ADDITIONAL INCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:
  • Serum creatinine within 2 weeks prior to MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).
  • ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:
  • The subject has known allergy to gadolinium
  • The subject has contraindications to MRI:
  • Subjects must weigh less than 136 kg (weight limit for scanner table).
  • Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.

Exclusion

    Key Trial Info

    Start Date :

    July 28 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 18 2011

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT01176500

    Start Date

    July 28 2010

    End Date

    November 18 2011

    Last Update

    July 2 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892