Trial Information

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

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.