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Anatomic Stage IV Breast Cancer AJCC v8Phase 1NCT04750473

Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer

A Phase 1 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga 68 Gozetotide in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Lobular Carcinoma, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) and PSMA PET/CT work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Fluciclovine F18 and Gallium Ga 68 Gozetotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Jul 2021to 21 Mar 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Treatment naive biopsy proven ILC patients with ILC
  • Either: a) clinical or imaging suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that could change therapy approach
  • Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach

Who cannot join

  • Pregnancy. Qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before PET
  • A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age > 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for > 1 year her reproductive status has to be verified by additional lab tests (< 20 estradiol OR estradiol < 40 with follicle-stimulating hormone [FSH] > 40 in women not on estrogen replacement therapy)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Phase 1 Feasibility Trial: Improved Staging of Lobular Breast Cancer With Novel Amino Acid Metabolic and Tumor Neovasculature Receptor Imaging

This phase I trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) and PSMA PET/CT work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body (metastasized). Fluciclovine and PSMA are radiotracers used in PET/CT imaging scans that emit radiation. The PET/CT scan than picks up the radiation being released to create a picture from within the body. Information learned from this study may help researchers learn how to better identify metastatic disease in invasive lobular breast cancer patients which will impact appropriate staging.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Improve detection of metastasis with fluciclovine F18 (fluciclovine) and gallium Ga 68-labeled PSMA-11 (PSMA) PET versus best standard of care conventional imaging, as confirmed with histology.

II. Determine concordance and discordance of invasive lobular breast cancer (ILC) detection with PSMA versus fluciclovine PET, as confirmed with histology.

EXPLORATORY OBJECTIVE:

  1. Establish the role of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) directed to ESR1 and PI3K DNA in characterizing the degree of tumor burden as identified by metabolic amino acid transport and tumor neovasculature receptor imaging.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo a PET/computed tomography (CT) scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes.

After completion of study, patients are followed up in 5-10 business days, and then up to 5 years.

Being tested
Computed Tomography, Fluciclovine F18, Gallium Ga 68 Gozetotide, Positron Emission Tomography
Medical subject headings
Carcinoma, Lobular

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 scan

  • Fluciclovine F18Drug

    Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC

    Given IV

  • Gallium Ga 68 GozetotideDrug

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT scan

Study groups in NCT04750473
Study groupRoleWhat they receive
Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)ExperimentalPatients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes.
Receives: Procedure: Computed Tomography; Drug: Fluciclovine F18; Drug: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verified Detection Rate for Metastasis

    Detection rates are compared between fluciclovine positron emission tomography (PET) and conventional imaging. Paired detection rates will be assessed using McNemar's test. Detection rates will be reported for each method, and 95% confidence intervals will be estimated using the Clopper-Pearson approach. Rates of concordant/discordant observations will be reported.

    Measured: Up to 105 days

  2. Verified Detection Rate for Invasive Lobular Breast Cancer

    Compared between gallium Ga 68-labeled PSMA-11 PET, fluciclovine PET, and conventional imaging. Paired detection rates will be assessed using McNemar's test. Detection rates will be reported for each method, and 95% confidence intervals will be estimated using the Clopper-Pearson approach. Rates of concordant/discordant observations will be reported.

    Measured: Up to 105 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start16 Jul 2021
  3. Primary completion21 Mar 2023
  4. Study completion21 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750473
Sponsor's protocol ID
STUDY00000675
Other IDs
NCI-2020-00366, WINSHIP4933-19, P30CA138292
Status last verified
Jan 2025
First submitted
9 Feb 2021
Last updated
17 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mushtaq A, Lawal IO, Muzahir S, Friend SC, Bhave M, Meisel JL, Torres MA, Styblo TM, Graham CL, Kalinsky K, Switchenko J, Ulaner GA, Schuster DM. Prospective investigation of amino acid transport and PSMA-targeted positron emission tomography for metastatic lobular breast carcinoma. Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4073-4082. doi: 10.1007/s00259-024-06830-7. Epub 2024 Jul 8.

    PubMed 38976035

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga 68 Gozetotide in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Lobular Carcinoma, run by Emory University 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 3 inclusion and 2 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 17 Jan 2025. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Verified Detection Rate for Metastasis (time frame: Up to 105 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04750473, which also lists 1 linked publication.

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 17 Jan 2025.

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