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PET Imaging with Copper Cu-64-DOTA-alendronate for Breast Cancer

Phase < 1

Waitlist Available

Led By Veronica Jones, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy confirmed malignancy associated calcifications in at least one breast

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days

Awards & highlights

Study Summary

This trial is testing a new imaging method to better detect and characterize breast calcifications. This may help doctors better predict if the calcifications are associated with cancer.

Who is the study for?

This trial is for individuals who can consent, are planning a mastectomy, have no liver or kidney issues, and show breast calcifications on mammograms. They must not be pregnant and should have biopsy-confirmed malignant and benign calcifications in at least one breast.Check my eligibility

What is being tested?

The study tests how well a new PET imaging technique using Copper Cu-64-DOTA-alendronate works in identifying and characterizing breast calcifications before mastectomy to help predict cancer-associated changes.See study design

What are the potential side effects?

Potential side effects may include reactions related to the injection of radioactive material used for PET imaging but specific side effects are not detailed as this is an early phase I pilot trial focusing on diagnostic procedure efficacy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have confirmed cancer-related calcium deposits in at least one breast.

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I have benign calcifications in at least one of my breasts.

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I am scheduled for a complete breast removal surgery.

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My liver and kidneys are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Side effects data

From 2023 Phase 2 trial • 257 Patients • NCT01333033

79%

Nausea

64%

Platelet count decreased

46%

Vomiting

46%

Neutrophil count decreased

41%

Paresthesia

41%

Diarrhea

38%

Lymphocyte count decreased

28%

Dysphagia

26%

Dyspnea

23%

Fatigue

21%

White blood cell decreased

18%

Anemia

15%

Anorexia

15%

Headache

13%

Peripheral motor neuropathy

13%

Dehydration

10%

Laryngopharyngeal dysesthesia

10%

Flu like symptoms

10%

Fever

10%

Hyponatremia

10%

Myalgia

Insomnia

Esophageal pain

Esophagitis

Chills

Weight loss

Hyperglycemia

Hypocalcemia

Arthralgia

Hypotension

Hypoalbuminemia

Sinus tachycardia

Pain

Bloating

Constipation

Hypokalemia

Peripheral sensory neuropathy

Aspiration

Alopecia

Skin and subcut tissue disord - Oth spec

Febrile neutropenia

Hypoxia

Soft tissue infection

Hypophosphatemia

Depression

Pharyngolaryngeal pain

Dysgeusia

Gastroparesis

Pain in extremity

Edema limbs

Stomach pain

Cardiac arrest

Thrombotic thrombocytopenic purpura

Esophageal hemorrhage

Esophageal obstruction

Lung infection

Sepsis

Tooth infection

Alkaline phosphatase increased

Back pain

Atelectasis

Cough

Epistaxis

Hiccups

Hoarseness

Pleural effusion

Pleuritic pain

Rash maculo-papular

Hypertension

Phlebitis

Superficial thrombophlebitis

Vascular disorders - Other, specify

Thromboembolic event

Blood and lymph sys disorders - Oth Spec

Palpitations

Sinus bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

FOLFOX Non-Responder

CP Responder

FOLFOX Responder

CP Non-Responder

CP No Cross-over

FOLFOX No Cross-over

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720