Clinical trial · Interventional
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Calcification | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Copper Cu-64-DOTA-alendronate | Drug | — | UNRESOLVED |
| Pharmacokinetic Study | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Drug: Copper Cu-64-DOTA-alendronate
- Other: Pharmacokinetic Study
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications
- timeFrame
- Up to 7 days
- description
- Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available