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

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04750473
• Other study ID #: STUDY00000675
• Secondary ID: NCI-2020-00366WI
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Drug:
• Fluciclovine F18
Given IV
• Gallium Ga 68 Gozetotide
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence or absence of metastasis	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	Up to 5 years
Other	Imaging results	Will correlate ctDNA results with the results of imaging.	Up to 5 years
Primary	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.	Up to 5 years
Primary	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.	Up to 5 years