Trial Outcomes & Findings for [18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma (NCT NCT04252859)
NCT ID: NCT04252859
Last Updated: 2025-05-18
Results Overview
The number of known ILC sites that demonstrate abnormal FES uptake by FES-PET/CT, defined as focal uptake above background with standardized uptake value (SUV) max of 1.5 or greater, relative to the total number of known ILC sites.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
At time of baseline FES-PET/CT imaging
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
Pilot Phase
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one Fluorine-18 (18F) -Fluoroestradiol (FES) positron emission tomography/computed tomography (PET/CT) scan and one optional 18F-fluorodeoxyglucose (FDG) PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 millicurie (mCi) and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-fluorodeoxyglucose (FDG) PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
25
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma
Baseline characteristics by cohort
| Measure |
Pilot Phase
n=17 Participants
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
|
Expansion Phase
n=25 Participants
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 13.5 • n=93 Participants
|
61.4 Years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
60.7 Years
STANDARD_DEVIATION 12.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At time of baseline FES-PET/CT imagingPopulation: This primary endpoint was evaluated using data collected during Pilot Phase only.
The number of known ILC sites that demonstrate abnormal FES uptake by FES-PET/CT, defined as focal uptake above background with standardized uptake value (SUV) max of 1.5 or greater, relative to the total number of known ILC sites.
Outcome measures
| Measure |
Pilot Phase
n=25 Lesions
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Positive Detection Rate of Invasive Lobular Carcinoma (ILC)
|
22 Lesions
|
—
|
PRIMARY outcome
Timeframe: At time of baseline FES-PET/CT imagingPopulation: This primary endpoint was evaluated using data collected during Expansion Phase only.
Blinded analysis was performed to determine staging fore each patient using FES-PET/CT imaging only and compared to the clinical stage assigned to each patient using a standard-of-care evaluation.
Outcome measures
| Measure |
Pilot Phase
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
n=25 Participants
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Change in Staging of Patients With Newly Diagnosed ILC
|
—
|
9 Participants
|
SECONDARY outcome
Timeframe: At time of baseline FES-PET/CT imagingPopulation: This secondary endpoint was evaluated using data collected during Pilot Phase only.
The number of known ER+ ILC sites that do not demonstrate abnormal FES uptake by FES-PET/CT, defined as focal uptake above background with SUV max of 1.5 or greater, relative to the total number of known ER+ ILC sites.
Outcome measures
| Measure |
Pilot Phase
n=20 Lesions
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Rate of Estrogen Receptor Positive (ER+) ILC That Does Not Demonstrate Positive FES Uptake
|
3 Lesions
|
—
|
SECONDARY outcome
Timeframe: This secondary endpoint was evaluated using data collected during Pilot Phase only.Population: This secondary endpoint was evaluated using data collected during Pilot Phase only.
The number of known ER- ILC sites that demonstrate abnormal FES uptake by FES-PET/CT, defined as focal uptake above background with SUV max of 1.5 or greater, relative to the total number of known ER- ILC sites.
Outcome measures
| Measure |
Pilot Phase
n=1 Lesion
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Rate of Estrogen Receptor Negative (ER-) ILC That Does Demonstrate Positive FES Uptake
|
1 Lesion
|
—
|
SECONDARY outcome
Timeframe: At time of baseline FES-PET/CT imagingPopulation: This secondary endpoint was evaluated using data collected during Pilot Phase only.
Number of patients demonstrating a presence of FES uptake with SUV max of 1.5 or greater in some but not all biopsy proven or suspected metastatic lesions.
Outcome measures
| Measure |
Pilot Phase
n=17 Participants
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Rate of Same-patient (Inter-tumoral) Heterogeneous FES Uptake
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At time of baseline FES-PET/CT imaging and FDG-PET/CT (done within four weeks of FES-PET/CT imaging)Population: This secondary endpoint was evaluated using data collected during Pilot Phase only.
Differences between FDG- and FES uptake. Discordant uptake will be evaluated for any histologically confirmed site of ILC before or after enrollment. Only lesions in patients who underwent both FES- and FDG-PET/CT scans will be included in this assessment. Discordant uptake is defined as individual lesions that show either positive FES uptake and negative FDG uptake, or negative FES uptake and positive FDG uptake.
Outcome measures
| Measure |
Pilot Phase
n=23 Lesions
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Rate of Discordant Uptake (FES Positive/FDG Negative or FES Negative/FDG Positive)
FES positive/FDG negative
|
4 Lesions
|
—
|
|
Rate of Discordant Uptake (FES Positive/FDG Negative or FES Negative/FDG Positive)
FES negative/FDG positive
|
1 Lesions
|
—
|
|
Rate of Discordant Uptake (FES Positive/FDG Negative or FES Negative/FDG Positive)
FES postive/FDG positive
|
16 Lesions
|
—
|
|
Rate of Discordant Uptake (FES Positive/FDG Negative or FES Negative/FDG Positive)
FES negative/FDG negative
|
2 Lesions
|
—
|
SECONDARY outcome
Timeframe: At time of baseline FES-PET/CT imaging and FDG-PET/CT (done within four weeks of FES-PET/CT imaging)Population: This outcome measure is not applicable for the expansion phase.
SUVmax values are compared for FES- and FDG-PET/CT within sites of abnormal uptake.
Outcome measures
| Measure |
Pilot Phase
n=19 Lesions
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Correlation of Lesion Uptake Between FES and FDG.
FES Treated Lesions
|
3.79 Lesions
Interval 2.51 to 6.3
|
—
|
|
Correlation of Lesion Uptake Between FES and FDG.
FDG-PET/CT Treated Lesions
|
3.97 Lesions
Interval 2.62 to 6.59
|
—
|
SECONDARY outcome
Timeframe: At time of baseline FES-PET/CT imagingPopulation: This endpoint could not be evaluated due to technical issues encountered during ctDNA analysis.
This outcome measure will assess whether the quantity of methylated ctDNA at baseline predicts patient stage at presentation per the American Joint Committee on Cancer (AJCC) TNM system. Spearman correlation would be used to assess the correlation between circulating tumor DNA (ctDNA) and stage. This outcome measure can not be reported as technical issues prevented the ctDNA analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: ctDNA samples collected for all patients at baseline and collected at 6, 12, 18, 24, 36, 48, and 60 months after baseline for patients who consented to additional collectionPopulation: This endpoint could not be evaluated due to technical issues encountered during ctDNA analysis.
To assess whether quantity of methylated ctDNA at baseline predicts survival at each follow-up interval starting at 6 months (follow-up performed at 6, 12, 18, 24, 36, 48 and 60 months). A proportional hazards model will be used to assess the relationship between methylated ctDNA and overall survival. To determine the relationship at various time points, the analysis will be performed with censoring at 6, 12, 18, 24, 36, 48 and 60 months. This outcome measure can not be reported as technical issues prevented the ctDNA analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Survival is assessed from baseline to study closure (up to 27 months from baseline FES-PET/CT)Population: Only three participants were evaluable for this endpoint, none had heterogeneous FES-PET/CT uptake at baseline.
To assess whether heterogeneous FES-PET/CT uptake at baseline (yes/no), defined as abnormal FES uptake in some but not all proven or suspected ILC lesions, predicts survival at each follow-up interval starting at 6 months (follow-up performed at 6, 12, 18 months). Due to early termination of the study, subject are censored at the end of study date. No participants had heterogeneous FES-PET/CT uptake at baseline. No participants died on study.
Outcome measures
| Measure |
Pilot Phase
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
n=3 Participants
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Relationship Between Presence of Heterogeneous FES-PET/CT Uptake at Baseline and Overall Survival
|
—
|
25.5 months
Interval 21.67 to 46.82
|
Adverse Events
Pilot Phase
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Expansion Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pilot Phase
n=17 participants at risk
Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan and one optional 18F-FDG PET/CT(if a standard of care scan not already performed).
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
Expansion Phase
n=25 participants at risk
Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT.
For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection.
For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.
\[18F\]Fluoroestradiol (FES) PET/CT: \[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Number of events 3 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Number of events 2 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Number of events 2 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Gastrointestinal disorders
Belching
|
5.9%
1/17 • Number of events 1 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
0.00%
0/25 • Adverse events and Serious Adverse Events were followed while the subjects were on the study; up to 3 days from initiation of the study intervention. Due to early termination of the study, survival was censored at the study completion date. Survival was followed for up to 27.1 months from baseline.
|
Additional Information
Sam Mitchell
Huntsman Cancer Institute, Center for Quantitative Cancer Imaging
Phone: 801-213-6110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place