- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00040430
Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
June 23, 2005 updated by: Copharos
The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of breast cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Roseville, California, United States, 95661
- Sutter Roseville Medical Center
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New York
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Buffalo, New York, United States, 14214-3007
- University at Buffalo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
Patients will be eligible for the study if they:
- Are non-pregnant, non-lactating females 18 years of age or older(must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
- Are being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast)
- Have been previously scheduled for biopsy or surgical excision of the known or suspected tumor of the breast
- Have signed an informed consent form
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
- Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
- Are taking or have taken part in any investigational study within 30 days of start of study
- Have received an indium agent within 30 days of start of study
- Are not able to remain immobile during scanning time
- Have taken drugs that may damage the kidneys within 2 weeks of start of study
- Have abnormal laboratory test results: hemoglobin < 9.5 gms/dl, serum creatinine > 1.5 mg/100ml, alkaline phosphatase 2X the upper limit of normal
- Have undergone an excisional and/or needle localization biopsy within 4 days prior to start of study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 26, 2002
First Submitted That Met QC Criteria
June 27, 2002
First Posted (Estimate)
June 28, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
January 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on 111In-DAC
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CopharosUnknownCarcinoma, Non-Small-Cell Lung | Lung Neoplasms | Brain Neoplasms | Metastases, NeoplasmUnited States
-
IpsenWithdrawnColorectal Cancer | Pancreatic Ductal AdenocarcinomaBelgium, France
-
Radboud University Medical CenterCompleted
-
National Institute of Neurological Disorders and...CompletedMultiple Sclerosis | Multiple Sclerosis, Relapsing-RemittingUnited States
-
Waisenmedizin e. V. Promoting Access to Essential...University of Freiburg; Waisenmedzin eV PACEM non-profit German NGO; German Medical... and other collaboratorsCompletedWound HealingAfghanistan
-
Fusion Pharmaceuticals Inc.TerminatedBreast Cancer | Gastric Cancer | Colorectal Cancer | Ovarian Cancer | Lung Cancer | Advanced Solid Tumor | Head and Neck Squamous Cell Carcinoma | Liver Cancer | Bladder Carcinoma | Susceptible FGFR3 Genetic Alterations | FGFR3 | FGFR3 Overexpression | FGFR3 Receptor | FGFR3 Protein OverexpressionUnited States, Australia
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SpectronRXJanssen Research & Development, LLC; Invicro; Tomopath Inc.TerminatedMetastatic Disease | Castration-Resistant Prostatic CancerUnited States
-
Daniel LandiTerminatedGlioblastoma | GliosarcomaUnited States
-
Fusion Pharmaceuticals Inc.AstraZenecaRecruitingAdvanced Solid Tumor | Non-small Cell Lung Cancer | Head and Neck Squamous Cell Carcinoma | Pancreatic Ductal Adenocarcinoma | Metastatic Colorectal CarcinomaUnited States, Canada
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Fusion Pharmaceuticals Inc.RecruitingGastric Cancer | Colorectal Cancer | Ewing Sarcoma | Squamous Cell Carcinoma of Head and Neck | Pancreatic Ductal Adenocarcinoma (PDAC) | NTSR1 Expressing Solid Tumours | Neuroendocrine Differentiated (NED) Prostate CancerUnited States, Australia