Raw Ground Truth
Inclusion Criteria:Males or females that have provided consent and are currently enrolled in BIOCARD studyAbility to tolerate PET scan proceduresAbility to provide informed consent for study proceduresExclusion Criteria:Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigatorHas a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.Has ECG acquired prior to initial 18F-AV-1451 scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.Has hypersensitivity to 18F-AV-1451.Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to 18F-AV-1451 imaging visit.Is unsuitable for a study of this type in the opinion of the investigator.
Raw Prediction
Amended Eligibility Criteria (version 2):
Inclusion Criteria:
- Males or females that have provided consent and are currently enrolled in the BIOCARD protocol.
- Ability to tolerate PET scan procedures.
- Ability to provide informed consent for study procedures.
- Have not experienced any condition by history or abnormal findings on physical examination or screening tests that, in the investigator’s opinion, could increase risk to the participant, limit the participant’s ability to tolerate the experimental procedures, or interfere with analysis of the data.
- Have not had an ECG obtained prior to the initial flortaucipir (18F) scan that in the opinion of the investigator is clinically significant with regard to the subject’s participation in the study.
- Are not females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception.
- Have not had hypersensitivity to flortaucipir (18F) or any of its excipients.
- Do not have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results.
- Have not had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the flortaucipir (18F) imaging session.
- Are not unsuitable for a study of this type in the opinion of the investigator.
Exclusion Criteria:
- Have a history of risk factors for Torsades de Pointes or are taking medications known to prolong QT interval.
- Have a history of risk factors for Torsades de Pointes or are taking medications known to prolong QT interval.
- Have ECG acquired prior to initial flortaucipir (18F) scan that clinically contradicts subject's participation in the study as determined by the investigator.
- Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
- Have hypersensitivity to flortaucipir (18F) or any of its excipients.
- Have a currently clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
- Have a non-study related radiopharmaceutical imaging or treatment procedure within seven days prior to 18F-AV-1451 imaging visit.
- In the opinion of the investigator, are otherwise unsuitable for a study of this type.
Processed Ground Truth
1. Males or females that have provided consent and are currently enrolled in BIOCARD studyAbility to tolerate PET scan proceduresAbility to provide informed consent for study proceduresExclusion Criteria:Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigatorHas a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.Has ECG acquired prior to initial 18F-AV-1451 scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.Has hypersensitivity to 18F-AV-1451.Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to 18F-AV-1451 imaging visit.Is unsuitable for a study of this type in the opinion of the investigator.
Processed Prediction
1. Amended Eligibility Criteria (version 2):
1. Males or females that have provided consent and are currently enrolled in the BIOCARD protocol.
2. Ability to tolerate PET scan procedures.
3. Ability to provide informed consent for study procedures.
4. Have not experienced any condition by history or abnormal findings on physical examination or screening tests that, in the investigator’s opinion, could increase risk to the participant, limit the participant’s ability to tolerate the experimental procedures, or interfere with analysis of the data.
5. Have not had an ECG obtained prior to the initial flortaucipir (18F) scan that in the opinion of the investigator is clinically significant with regard to the subject’s participation in the study.
6. Are not females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception.
7. Have not had hypersensitivity to flortaucipir (18F) or any of its excipients.
8. Do not have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results.
9. Have not had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the flortaucipir (18F) imaging session.
10. Are not unsuitable for a study of this type in the opinion of the investigator.
1. Have a history of risk factors for Torsades de Pointes or are taking medications known to prolong QT interval.
2. Have a history of risk factors for Torsades de Pointes or are taking medications known to prolong QT interval.
3. Have ECG acquired prior to initial flortaucipir (18F) scan that clinically contradicts subject's participation in the study as determined by the investigator.
4. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
5. Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
6. Have hypersensitivity to flortaucipir (18F) or any of its excipients.
7. Have a currently clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
8. Have a non-study related radiopharmaceutical imaging or treatment procedure within seven days prior to 18F-AV-1451 imaging visit.
9. In the opinion of the investigator, are otherwise unsuitable for a study of this type.