Trial Outcomes & Findings for Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer (NCT NCT04750473)

Last Updated: 2025-01-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Up to 105 days

Results posted on

2025-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Ga PSMA, Fluciclovine F18, PET/CT) 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Ga PSMA, Fluciclovine F18, PET/CT) n=20 Participants 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 105 days

Outcome measures

Outcome measures
Measure	F-Fluciclovine n=20 Participants 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan	Ga-PSMA-11 n=20 Participants 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan
Verified Detection Rate for Metastasis	5.9 SUVMax Interval 3.0 to 8.8	5.5 SUVMax Interval 0.3 to 10.7

PRIMARY outcome

Timeframe: Up to 105 days

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.

Outcome measures

Outcome measures
Measure	F-Fluciclovine n=20 Participants 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan	Ga-PSMA-11 n=20 Participants 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. Computed Tomography: Undergo PET/CT scan Fluciclovine F18: Given IV Gallium Ga 68 Gozetotide: Given IV Positron Emission Tomography: Undergo PET/CT scan
Verified Detection Rate for Invasive Lobular Breast Cancer	7.8 SUVMax Interval 5.1 to 10.5	4.6 SUVMax Interval 2.9 to 6.3

Adverse Events

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Schuster

Emory University/Winship Cancer Institute

Phone: 404-712-4859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place