The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer

NCT ID: NCT01503697

Last Updated: 2012-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31

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.

Detailed Description

Angiogenesis is the formation of new blood vessels from the existing vascular bed. Certain integrins are upregulated while angiogenesis and myocardial fibrogenesis. Therefore, targeting an integrin with an imaging agent can be potentially useful for the early diagnosis of angiogenesis and/or fibrogenesis of malignant processes and myocardial remodelling.

Trail design

Arm 1:

Study cohort will include 30 patients. After the IV injection of 630-700 MBq 99mTc-NC100692 each breast will be imaged in CC and oblique views using the MBI system. Scintigarphic findings will be correlated with tissue diagnosis and or/ imaging and clinical follow- up of at least 6 months as well as with MRI, if performed, in order to determine the PPV and the NPV of the technology of MBI with labeled NC100692 for detection of tumors and differentiating benign and malignant breast lesions.

Arm 2 :

Study cohort will include 30 patients with breast cancer referred for 18-FDG PET-CT for staging or re-staging. In addition to the PET-CT study, scintimammography using the MBI system and whole-body scintigraphy using the Infinia gamma-camera will be performed after the IV injection of 630-700 MBq 99mTc-NC100692. Imaging with 99mTc-NC100692 will be take place first followed by 18-FDG PET-CT, on the same day.

Detection of the primary tumor, lymph nodes and remote metastasis by the various modalities and tracers will be correlated.

Arm 3:

Study cohort will include 15 patients with locally advanced breast cancer. Patients will undergo scintimammography with the MBI system (for the breast) and SPECT of the axilla and thorax (for regional lymph nodes) with the Infinia gamma camera, after the IV injection of 630-700 MBq 99mTc-NC100692 prior to treatment and at its end. The results of the follow-up studies will be correlated with histological findings in patients referred for surgery and with MRI in others.

Prior to the exam, patients will answer a detailed questionnaire about medical and family history,findings on other imaging modalities and,therpy.

The patient will be guided by the study coordinator before answering the questionnaire Reading of the 99mTc-NC100692 studies will be in a blinded mode to other imaging data, separately by two nuclear medicine experts and then in consensus. Mammography, US and MRI will be reviewed by a breast imaging.

Conditions

Breast Cancer; Tumor Angiogenesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michal Roll PhD,MBA

director, R&D Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Einat Even-Sapir Weizer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Nuclear Medicine,Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Orit Goldray, M.Sc.

Role: CONTACT

oritgold@tasmc.health.gov.il

972-3-6974373

Prof. Einat Even-Sapir Weizer, MD, PhD

Role: CONTACT

evensap@tasmc.health.gov.il

972-3-6973536

Facility Contacts

Orit Goldray, M.Sc.

Role: primary

oritgold@tasmc.health.gov.il

972-3-6974373

References

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.

Reference Type: BACKGROUND

PMID: 11875744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1688381 (View on PubMed)

Other Identifiers

TASMC-11-EE-262-CTIL

Identifier Type: -

Identifier Source: org_study_id