64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
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|ClinicalTrials.gov Identifier: NCT03542695|
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Calcification||Procedure: Computed Tomography Drug: Copper Cu-64-DOTA-alendronate Other: Pharmacokinetic Study Procedure: Positron Emission Tomography||Early Phase 1|
I. To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.
I. To compare uptake of 64Cu-DOTA-alendronate on PET -computed tomography (CT) with histology after mastectomy.
OUTLINE: This is a dose-escalation study of 64Cu-DOTA-alendronate.
Participants receive 64Cu-DOTA-alendronate intravenously (IV) and undergo PET/CT imaging 60 minutes after injection. Participants with sufficient levels of residual radioactivity may undergo repeat imaging on day 1 as determined by the study team.
After completion of study , participants are followed up for 7 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||December 7, 2020|
|Estimated Study Completion Date :||December 7, 2020|
Experimental: Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
Participants receive 64Cu-DOTA-alendronate IV and undergo PET/CT imaging 60 minutes after injection. Participants with sufficient levels of residual radioactivity may undergo repeat imaging on day 1 as determined by the study team.
Procedure: Computed Tomography
Drug: Copper Cu-64-DOTA-alendronate
Other Name: 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate
Other: Pharmacokinetic Study
Procedure: Positron Emission Tomography
- Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications [ Time Frame: Up to 7 days ]Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.
- Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy [ Time Frame: Up to 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542695
|United States, California|
|City of Hope Medical Center||Not yet recruiting|
|Duarte, California, United States, 91010|
|Contact: Veronica C. Jones, MD 626-471-7100 firstname.lastname@example.org|
|Principal Investigator: Veronica C. Jones, MD|
|Principal Investigator:||Veronica Jones, MD||City of Hope Medical Center|