Oncology Clinical Trial Finder

Breast Cancer

Active, not recruiting • Phase O • Stage 0, I, II, III, IV • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy

This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.

PRIMARY OBJECTIVES: I. To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications. SECONDARY OBJECTIVES: 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.

Breast Cancer

Study Design

Study type:


Estimated enrollment:

1 participant

Actual study start date:

November 3, 2021

Eligibility Criteria

Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention

  • Computed Tomography

  • Copper Cu-64-DOTA-alendronate

  • Pharmacokinetic Study

  • Positron Emission Tomography

Inclusion criteria

  • evidence of calcifications on mammogram

  • biopsy confirmed malignancy associated calcifications in at least one breast

  • biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)

  • planned total mastectomy for treatment

  • ability to provide informed consent

  • negative serum pregnancy test

  • no evidence of impaired hepatic or kidney function

Exclusion criteria

  • participants who do not have residual calcifications present on mammogram following biopsy

  • concurrent malignancy other than non-melanoma skin cancer

  • patients with known metastatic disease

  • patients who have received prior treatment for the current breast cancer

  • patients currently using oral bisphosphonate therapy

  • patients with injection of other radioactive material within 90 days

  • inability to provide informed consent

  • pregnant or lactating patients

  • patients with impaired kidney function (creatinine >= 1.3 mg/dl or < 0.6 mg/dl)

Trial Information at Site

Last Updated:

Trial Information

ClinicalTrial.gov ID:

Active, not recruiting

Estimated Enrollment:


Last Updated:


Principal Investigator

Veronica Jones, MD

Trial Sponsor

City of Hope Medical Center

Study Location (1)

City of Hope Medical Center

Duarte, California, United States


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