Breast CancerNCT01503697
The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer
An observational study of Breast Cancer and Tumor Angiogenesis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Tumor Angiogenesis
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients with breast cancer who do not fall into one of the three study arms.
- Pregnant or lactating females.
- Participation in another investigational study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Nuclear Medicine,Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Orit Goldray, M.Sc., 972-3-6974373, oritgold@tasmc.health.gov.il
Prof. Einat Even-Sapir Weizer, MD, PhD
About this study
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.
Read more
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.
Read the 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
- Keywords
- Breast Cancer, High Risk, Imaging, Angiogenesis
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- Prof. Einat Even-Sapir Weizer, MD, PhD, Principal investigator, Head, Department of Nuclear Medicine,Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503697
- Sponsor's protocol ID
- TASMC-11-EE-262-CTIL
- Status last verified
- Jan 2012
- First submitted
- 1 Jan 2012
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11875744Folkman 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.
PubMed 1688381
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer
- ClinicalTrials.gov ID
- NCT01503697
- Acronym / sponsor ID
- TASMC-11-EE-262-CTIL
- Conditions
- Breast Cancer, Tumor Angiogenesis
- Keywords
- Breast Cancer, High Risk, Imaging, Angiogenesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2012
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with breast cancer who do not fall into one of the three study arms.
- Pregnant or lactating females.
- Participation in another investigational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
- Background: PubMed 11875744Buerkle 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.
- Background: PubMed 1688381Folkman 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Einat Even-Sapir Weizer, MD, PhD principal investigator
Head, Department of Nuclear Medicine,Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Tumor Angiogenesis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orit Goldray, M.Sc. (972-3-6974373, oritgold@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2012.