Trial Outcomes & Findings for Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer (NCT NCT03111914)
NCT ID: NCT03111914
Last Updated: 2023-01-20
Results Overview
Feasibility of monitoring metastatic bone disease in prostate cancer patients
TERMINATED
NA
7 participants
Duration of CT scan (approximately 5 minutes)
2023-01-20
Participant Flow
Participant milestones
| Measure |
Dual Energy Computed Tomography (DECT)
This is a single-arm study. Each patient will receive an unenhanced dual energy CT scan followed by a contrast-enhanced scan as part of clinical routine work up. No change in the contrast material injection protocol will be performed for this this study.
Dual Energy Computed Tomography: The subject's diagnostic scan will be preceded by a not clinically indicated non enhanced dual energy scan. The overall radiation dose to the patient for the first and second acquisition will be twice the radiation dose of a conventional CT of the chest, abdomen and pelvis. The non enhanced dual energy scan will be repeated during a clinical follow-up after the subject's first three months of enrollment and at a clinical follow-up after six months of enrollment.
The clinically-indicated, contrast-enhanced diagnostic scan will be performed according to standard of care.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Applications of Dual Energy CT in Patients With Osseous Metastases From Castrate-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dual Energy Computed Tomography (DECT)
n=7 Participants
This is a single-arm study. Each patient will receive an unenhanced dual energy CT scan followed by a contrast-enhanced scan as part of clinical routine work up. No change in the contrast material injection protocol will be performed for this this study.
Dual Energy Computed Tomography: The subject's diagnostic scan will be preceded by a not clinically indicated non enhanced dual energy scan. The overall radiation dose to the patient for the first and second acquisition will be twice the radiation dose of a conventional CT of the chest, abdomen and pelvis. The non enhanced dual energy scan will be repeated during a clinical follow-up after the subject's first three months of enrollment and at a clinical follow-up after six months of enrollment.
The clinically-indicated, contrast-enhanced diagnostic scan will be performed according to standard of care.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
To analyze the feasibility to detect bone metastasis at baseline more accurately, unenhanced bone marrow imaging will be calculated and additional dual energy based, calcium corrected iodine maps will be used to determine a threshold for detection of vital bone metastasis in order to calculate color coded bone maps for risk of presence of bone metastases.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of CT scan (approximately 5 minutes)Population: Data not collected due to technical issues.
Feasibility of monitoring metastatic bone disease in prostate cancer patients
Outcome measures
Outcome data not reported
Adverse Events
Dual Energy Computed Tomography (DECT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place