Breast CarcinomaEarly Phase 1NCT03542695
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
A Early Phase 1 study testing Computed Tomography, Copper Cu-64-DOTA-alendronate and Pharmacokinetic Study in people with Breast Carcinoma and Calcification, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Calcification
- What is being tested?
- Computed Tomography, Copper Cu-64-DOTA-alendronate and Pharmacokinetic Study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 31 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma, Calcification
- Being tested
- Computed Tomography, Copper Cu-64-DOTA-alendronate, Pharmacokinetic Study, Positron Emission Tomography
- Medical subject headings
- Breast Neoplasms, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Copper Cu-64-DOTA-alendronateDrug
Also called 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate
Given IV
Pharmacokinetic StudyOther
Also called PHARMACOKINETIC, PK Study
Correlative studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Drug: Copper Cu-64-DOTA-alendronate; Other: Pharmacokinetic Study; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days
Secondary outcomes (1)
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start3 Nov 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Veronica Jones, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542695
- Sponsor's protocol ID
- 18112
- Other IDs
- NCI-2018-00890, 18112
- Status last verified
- Jun 2024
- First submitted
- 18 May 2018
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications
- ClinicalTrials.gov ID
- NCT03542695
- Acronym / sponsor ID
- 18112
- Conditions
- Breast Carcinoma, Calcification
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the uptake (maximum standardized uptake value [SUVmax]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (64Cu-DOTA-alendronate, PET/CT scan) | Experimental | Procedure: Computed Tomography, Drug: Copper Cu-64-DOTA-alendronate, Other: Pharmacokinetic Study, Procedure: Positron Emission TomographyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT | Procedure or surgery | Diagnostic (64Cu-DOTA-alendronate, PET/CT scan) |
| Copper Cu-64-DOTA-alendronateAlso: 64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronateGiven IV | Drug | Diagnostic (64Cu-DOTA-alendronate, PET/CT scan) |
| Pharmacokinetic StudyAlso: PHARMACOKINETIC, PK StudyCorrelative studies | Other | Diagnostic (64Cu-DOTA-alendronate, PET/CT scan) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Diagnostic (64Cu-DOTA-alendronate, PET/CT scan) |
Primary outcome
Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications
Time frame: Up to 7 days
Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.
1 secondary outcome
Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Jones, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Copper Cu-64-DOTA-alendronate and Pharmacokinetic Study in people with Breast Carcinoma and Calcification, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.