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

Primary Purpose

Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Lobular Carcinoma, Metastatic Breast Lobular Carcinoma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Fluciclovine F18

Gallium Ga 68 Gozetotide

Positron Emission Tomography

About this trial

This is an interventional diagnostic trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Emory University Hospital/Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)

Arm Description

Patients 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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04750473

First Posted

February 9, 2021

Last Updated

May 11, 2023

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT04750473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 16, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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 (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.

Detailed Description

PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Lobular Carcinoma, Metastatic Breast Lobular Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)

Arm Type

Experimental

Arm Description

Patients 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.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Intervention Description

Undergo PET/CT scan

Intervention Type

Drug

Intervention Name(s)

Fluciclovine F18

Other Intervention Name(s)

(18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Gallium Ga 68 Gozetotide

Other Intervention Name(s)

(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, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo PET/CT scan

Primary Outcome Measure Information:

Title

Verified detection rate for metastasis

Description

Time Frame

Up to 5 years

Title

Verified detection rate for invasive lobular breast cancer

Description

Time Frame

Up to 5 years

Other Pre-specified Outcome Measures:

Title

Presence or absence of metastasis

Description

Will correlate circulating tumor deoxyribonucleic acid (ctDNA) results with the presence or absence of metastasis. ctDNA parameters will be summarized descriptively using mean, median, minimum/maximum, interquartile range, and standard deviation. ctDNA will be correlated with positron emission tomography uptake parameters using Pearson's or Spearman's correlation coefficient (where appropriate), as well as chi-squared tests, Fisher's exact tests, or analysis of variance if any variables are further categorized

Time Frame

Up to 5 years

Title

Imaging results

Description

Will correlate ctDNA results with the results of imaging.

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Schuster, MD

Organizational Affiliation

Emory University Hospital/Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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