64 Cu-DOTA-alendronate PET Imaging in Localizing and Char... | NCT03542695

ID	Type	Description	Link
NCI-2018-00890	Registry Identifier	CTRP (Clinical Trial Reporting Program)
18112	Other Identifier	City of Hope Medical Center

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2021Actual

Primary Completion Date

May 31, 2024Actual

Completion Date

May 31, 2024Actual

First Submitted Date

May 18, 2018

First Submission Date that Met QC Criteria

May 18, 2018

First Posted Date

May 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2024

Last Update Posted Date

Jun 24, 2024Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Tomography Drug: Copper Cu-64-DOTA-alendronate Other: Pharmacokinetic Study Procedure: Positron Emission Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed Tomography	Procedure	Undergo PET/CT	Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy		Up to 7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronica Jones, MD	City of Hope Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Medical Center		Duarte	California	91010	United States

ID	Term
D001943	Breast Neoplasms
D002114	Calcinosis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000071184	Pharmacogenomic Variants
D009682	Magnetic Resonance Spectroscopy

ID	Term
D011110	Polymorphism, Genetic
D014644	Genetic Variation
D055614	Genetic Phenomena
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques