Clinical Trial Results:
16α-18F-fluor-17β-estradiol PET/CT for detection of estrogen receptor positive liver metastases in breast cancer
Summary
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EudraCT number |
2019-002665-35 |
Trial protocol |
DK |
Global end of trial date |
04 Oct 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Nov 2024
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First version publication date |
02 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
190619
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04150731 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Aarhus University Hospytal
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Sponsor organisation address |
Palle Juul Jensens Boulevard 99, Aarhus, Denmark, 8200
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Public contact |
Mette Abildgaard Pedersen, Aarhus University Hospital, +45 31411180, meabpe@biomed.au.dk
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Scientific contact |
Mette Abildgaard Pedersen, Aarhus University Hospital, +45 31411180, meabpe@biomed.au.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Oct 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Oct 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Oct 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate parametric and conventional FES-PET/CT as methods of quantification of estrogen receptor (ER) expression in patients with disseminated BC
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Protection of trial subjects |
GCP trail unit Aarhus University
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Oct 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
6
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
At oncology department , Aarhus University Hospital | ||||||
Pre-assignment
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Screening details |
Inclusion criteria: metastatic ER+, human epidermal growth factor receptor 2 negative (HER2-) BC (2) at least two liver metastases visualized on CT (3) treatment with aromatase inhibitors or chemotherapy (4) postmenopausal status. | ||||||
Period 1
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Period 1 title |
Overall trail (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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FES SCAN | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
18F-Fluoroestradiol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
200 MBq
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Baseline characteristics reporting groups
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Reporting group title |
Overall trail
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
FES uptake
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.
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Subject analysis set title |
FES Uptake Patlak
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
FES Uptake Patlak
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End points reporting groups
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Reporting group title |
FES SCAN
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Reporting group description |
- | ||
Subject analysis set title |
FES uptake
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.
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Subject analysis set title |
FES Uptake Patlak
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
FES Uptake Patlak
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End point title |
FES tumor to background | ||||||||||||
End point description |
Tumor to background FES uptake was increased with dynamic imaging compared to static imaging.
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End point type |
Primary
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End point timeframe |
2023
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Statistical analysis title |
t-test | ||||||||||||
Comparison groups |
FES uptake v FES Uptake Patlak
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [1] - t-test |
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Adverse events information
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Timeframe for reporting adverse events |
1 adverse event with back pain
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
FES exposure
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |