NCT03542695

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
3.4 years until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

May 18, 2018

Last Update Submit

June 21, 2024

Conditions

Breast CarcinomaCalcification

Outcome Measures

Primary Outcomes (1)

  • Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications

    Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.

    Up to 7 days

Secondary Outcomes (1)

  • Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy

    Up to 7 days

Study Arms (1)

Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)

EXPERIMENTAL

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 TomographyDrug: Copper Cu-64-DOTA-alendronateOther: Pharmacokinetic StudyProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
Copper Cu-64-DOTA-alendronateDRUG

Given IV

Also known as: 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
Pharmacokinetic StudyOTHER

Correlative studies

Also known as: PHARMACOKINETIC, PK Study
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCalcinosis

Interventions

Pharmacogenomic VariantsMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polymorphism, GeneticGenetic VariationGenetic PhenomenaSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Veronica Jones, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

November 3, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

US(1)