Trial Outcomes & Findings for Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography (NCT NCT02455453)
NCT ID: NCT02455453
Last Updated: 2020-01-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Completion of second FFNP-PET/CT scan (up to 4 weeks)
Results posted on
2020-01-14
Participant Flow
Participant milestones
| Measure |
Diagnostic FFNP-PET/CT Scan
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
|
|---|---|
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Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
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47
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
Baseline characteristics by cohort
| Measure |
Diagnostic FFNP-PET/CT Scan
n=47 Participants
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
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|---|---|
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Age, Continuous
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60.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
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47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of second FFNP-PET/CT scan (up to 4 weeks)Population: 2 participants were not included in this outcome measure as the liver background was too high in both participants.
Outcome measures
| Measure |
Diagnostic FFNP-PET/CT Scan
n=45 Participants
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
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|---|---|
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Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
|
11.0 percent change in SUV
Interval -46.0 to 306.0
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PRIMARY outcome
Timeframe: Completion of second FFNP-PET/CT scan (up to 4 weeks)Population: 12 participants were not included in this outcome measure as they did not have a secondary tumor location and 2 participants were not included in this outcome measure as the liver background was too high in both participants.
Outcome measures
| Measure |
Diagnostic FFNP-PET/CT Scan
n=33 Participants
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
|
|---|---|
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Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)
|
15.0 percent change in SUV
Interval -48.0 to 306.0
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SECONDARY outcome
Timeframe: Completion of second FFNP-PET/CT scan (up to 4 weeks)Population: 2 participants were not included in this outcome measure as the liver background was too high in both participants.
As measured visually in known lesion by recording presence or absence of uptake with note of any changes between scans
Outcome measures
| Measure |
Diagnostic FFNP-PET/CT Scan
n=45 Participants
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
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|---|---|
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Heterogeneity of Tumor FFNP Uptake as Measured by Number of Participants With Heterogenous Response
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6 Participants
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Adverse Events
Diagnostic FFNP-PET/CT Scan
Serious events: 0 serious events
Other events: 11 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic FFNP-PET/CT Scan
n=47 participants at risk
* (2) 18F-FFNP-PET/CT scans
* First one prior to estradiol challenge test
* Second one immediately following one day of estradiol challenge test
* (1) FDG-PET/CT scan at screening
* The estradiol challenge test will consist of administering a total of 6 mg of estradiol dosed orally as three 2 mg tablets with each tablet being administered approximately 8 hours apart and within a 24 hour period. This estradiol medication will be provided to the patient by the study.
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|---|---|
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Gastrointestinal disorders
Diarrhea
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6.4%
3/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Gastrointestinal disorders
Nausea
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6.4%
3/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Gastrointestinal disorders
Oral pain
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2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Gastrointestinal disorders
Vomiting
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4.3%
2/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Gastrointestinal disorders
Oral dysesthesia
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2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
|
Gastrointestinal disorders
Abdominal cramping
|
2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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General disorders
Fatigue
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4.3%
2/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Nervous system disorders
Cognitive disturbance
|
2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
2/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Musculoskeletal and connective tissue disorders
Shoulder/joint pain
|
2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
|
Nervous system disorders
Paresthesia
|
4.3%
2/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
|
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Skin and subcutaneous tissue disorders
Bug bite or welt
|
2.1%
1/47 • For FFNP-PET/CT imagings, participants were contacted by phone or in person approximately 24 +/- 6 hours after the injection of 18FFNP to assess for adverse events as related to 18F-FFNP injection, or PET/CT imaging. Any adverse events that occurred within 24 hours of administration of 18F-FFNP or within 24 hours of the first dose of estradiol which are graded related or possibly related were reported.
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Additional Information
Farrokh Dehdashti, M.D.
Washington University School of Medicine
Phone: 314-747-1604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place