Trial Outcomes & Findings for Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer (NCT NCT00520546)
NCT ID: NCT00520546
Last Updated: 2012-06-20
Results Overview
PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.
COMPLETED
PHASE3
44 participants
within < 2 weeks after PET/MRI
2012-06-20
Participant Flow
Enrollment of first patient: 18th. December, 2007 Completion by last patient: 12th. January, 2011 Single Center Study at Federal Armed Forces Hospital Ulm
44 patients were enrolled, 38 patients completed the study. 1 patient decided not to choose prostatectomy after Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI), although it was planned at point of enrollment. 5 patients did not get a PET/MRI-can because of failed radiopharmaceutical synthesis of \[18F\]fluoroethylcholine (FEC).
Participant milestones
| Measure |
FEC-PET/eMRI
The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq \[22Na\] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq \[18F\]fluoroethylcholine (FEC) as a bolus through the cubital vein.
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|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
FEC-PET/eMRI
The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq \[22Na\] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq \[18F\]fluoroethylcholine (FEC) as a bolus through the cubital vein.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
failed radiopharmaceut. synthesis of FEC
|
5
|
Baseline Characteristics
Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer
Baseline characteristics by cohort
| Measure |
FEC-PET/eMRI
n=44 Participants
The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq \[22Na\] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq \[18F\]fluoroethylcholine (FEC) as a bolus through the cubital vein.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=99 Participants
|
|
Age Continuous
|
65 years
STANDARD_DEVIATION 6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: within < 2 weeks after PET/MRIPopulation: Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).
PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.
Outcome measures
| Measure |
Magnetic Resonance Imaging (MRI)
n=38 Participants
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
|
PET/MRI
n=38 Participants
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
|
FEC-PET
n=38 Participants
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq \[18F\]Fluoroethylcholine chloride (FEC; Eckert \& Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
|
|---|---|---|---|
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Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
True Positive
|
26 participants
|
35 participants
|
36 participants
|
|
Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
False Positive
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
True Negative
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
False Negative
|
11 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
Total True
|
27 participants
|
36 participants
|
36 participants
|
|
Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings
Total False
|
11 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: within < 2 weeks after PET/MRIPopulation: Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).
PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.
Outcome measures
| Measure |
Magnetic Resonance Imaging (MRI)
n=128 lesions
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
|
PET/MRI
n=128 lesions
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
|
FEC-PET
n=128 lesions
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq \[18F\]Fluoroethylcholine chloride (FEC; Eckert \& Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
|
|---|---|---|---|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
True positive
|
40 lesions
|
55 lesions
|
59 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
False positive
|
27 lesions
|
8 lesions
|
26 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
True negative
|
18 lesions
|
37 lesions
|
19 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
False negative
|
43 lesions
|
28 lesions
|
24 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
Total true
|
58 lesions
|
92 lesions
|
78 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients
Total false
|
70 lesions
|
36 lesions
|
50 lesions
|
SECONDARY outcome
Timeframe: within < 2 weeks after PET/MRIPopulation: lesion based (patients with Gleasons Score \>6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38). Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated Gleason Score = histological primary grade + secondary grade (min=2,max=10)
PET positive lesions in patients with Gleason \>6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative \& positive predictive values were determined.
Outcome measures
| Measure |
Magnetic Resonance Imaging (MRI)
n=43 lesions
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
|
PET/MRI
n=43 lesions
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
|
FEC-PET
n=43 lesions
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq \[18F\]Fluoroethylcholine chloride (FEC; Eckert \& Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
|
|---|---|---|---|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
True positive
|
22 lesions
|
27 lesions
|
27 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
False positive
|
9 lesions
|
1 lesions
|
5 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
True negative
|
4 lesions
|
11 lesions
|
8 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
False negative
|
8 lesions
|
4 lesions
|
3 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
Total true
|
26 lesions
|
38 lesions
|
35 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)
Total false
|
17 lesions
|
5 lesions
|
8 lesions
|
SECONDARY outcome
Timeframe: within < 2 weeks after PET/MRIPopulation: lesion based (malignant lesions \>5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)
PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions \<=5mm.
Outcome measures
| Measure |
Magnetic Resonance Imaging (MRI)
n=98 lesions
The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
|
PET/MRI
n=98 lesions
PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
|
FEC-PET
n=98 lesions
PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq \[18F\]Fluoroethylcholine chloride (FEC; Eckert \& Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.
|
|---|---|---|---|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
True positive
|
37 lesions
|
48 lesions
|
48 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
False positive
|
26 lesions
|
8 lesions
|
24 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
True negative
|
16 lesions
|
32 lesions
|
18 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
False negative
|
19 lesions
|
10 lesions
|
8 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
Total true
|
53 lesions
|
80 lesions
|
66 lesions
|
|
Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)
Total false
|
45 lesions
|
18 lesions
|
32 lesions
|
Adverse Events
FEC-PET/eMRI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Major Medical Corps Dr. Markus Hartenbach
German Federal Armed Forces Hospital, Ulm
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place