NCT01503697

Brief Summary

Technetium-99m NC100692 Injection is under development as a diagnostic radiopharmaceutical for targeting angiogenesis associated with diseases such as primary and metastatic cancer, and for targeting active fibrosis in cardiac diseases such as developing heart failure and developing hypertrophic cardiomyopathy. A principle goal of imaging is identification of disease processes early in their development, at times prior to symptoms. In cancer, angiogenesis is essential for a tumour to exceed approximately 1-2 mm3 in size.As markers of angiogenesis are often expressed early in the growth of a tumour it is postulated that imaging of angiogenesis can assist in early diagnosis of cancer, relapse or spread, and monitoring response to therapy. Technetium-99m NC100692 Injection will be tested on 3 populations of pts: 1.30 patients at high risk For breast cancer 2.30 patients with breast cancer 3.15 patients with locally advanced breast cancer undergoing treatment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

January 4, 2012

Status Verified

January 1, 2012

First QC Date

January 1, 2012

Last Update Submit

January 3, 2012

Conditions

Breast CancerTumor Angiogenesis

Keywords

Breast CancerHigh RiskImagingAngiogenesis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Investigating the diagnostic accuracy of NC100692kit in three patient populations: Arm 1.Patients with unknown breast cancer but unclear lesions in the breast or other modalities or patients at high risk for breast cancer (BRCA, familial) Arm 2. Staging and re-staging in patients with breast cancer. Arm 3. Monitoring response to neo-adjuvant chemotherapy in patients with locally advanced breast cancer

You may qualify if:

  • Age ≥ 18 years.
  • Patients with unknown breast cancer but unclear lesions in the breast on other modalities or patients at high risk for breast cancer (BRCA, familial)- Arm 1
  • patients with breast cancer referred for 18-FDG PET-CT for staging or re-staging- Arm 2
  • Study cohort will include 15 patients with locally advanced breast cancer. Patients will undergo imaging prior to treatment and at its end- Arm 3
  • Written signed informed consent to participate in the study.
  • Patients not pregnant or lactating.

You may not qualify if:

  • Patients with breast cancer who do not fall into one of the three study arms.
  • Pregnant or lactating females.
  • Participation in another investigational study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine,Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (2)

  • Buerkle MA, Pahernik SA, Sutter A, Jonczyk A, Messmer K, Dellian M. Inhibition of the alpha-nu integrins with a cyclic RGD peptide impairs angiogenesis, growth and metastasis of solid tumours in vivo. Br J Cancer. 2002 Mar 4;86(5):788-95. doi: 10.1038/sj.bjc.6600141.

    PMID: 11875744BACKGROUND

  • Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. doi: 10.1093/jnci/82.1.4. No abstract available.

    PMID: 1688381BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Prof. Einat Even-Sapir Weizer, MD, PhD

    Head, Department of Nuclear Medicine,Tel Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orit Goldray, M.Sc.

CONTACT

972-3-6974373oritgold@tasmc.health.gov.il

Prof. Einat Even-Sapir Weizer, MD, PhD

CONTACT

972-3-6973536evensap@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director, R&D Division

Study Record Dates

First Submitted

January 1, 2012

First Posted

January 4, 2012

Study Start

January 1, 2012

Last Updated

January 4, 2012

Record last verified: 2012-01

Locations

IL(1)