ID

18940

Description

Safety and Efficacy of Folatescan (Technetium TC 99M EC20) in Patients With Suspected Ovarian Carcinoma or Recurrent Endometrial Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01689714

Link

https://clinicaltrials.gov/show/NCT01689714

Keywords

  1. 11/18/16 11/18/16 -
  2. 11/25/16 11/25/16 -
Uploaded on

November 25, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Ovarian Carcinoma NCT01689714

Eligibility Ovarian Carcinoma NCT01689714

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must meet the following eligibility requirements to be enrolled in the study.
Description

Clinical Trial Eligibility Criteria Requirement

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1514873
1. subject must be 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed by ultrasonography, mri, or ct.
Description

Ovarian Carcinoma | Recurrent Endometrial Cancer | Lesion size | Lesion Quantity | Ultrasonography | Magnetic Resonance Imaging | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0278802
UMLS CUI [3]
C0449453
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0041618
UMLS CUI [6]
C0024485
UMLS CUI [7]
C0040405
3. subject must have good kidney function.
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
4. subject must provide written informed consent prior to enrollment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must be excluded if any of the following conditions are present:
Description

Condition Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0150312
1. subject is pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. subject is simultaneously participating in another investigational drug study.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
3. subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
Description

Clinical Study Follow-up Previous Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0205197
4. subject is unable to tolerate conditions for radionuclide imaging.
Description

Radionuclide Imaging Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0034606
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
5. subject has been administered another radiopharmaceutical that would interfere with the assessment of technetium tc 99m ec20.
Description

Radiopharmaceutical Interferes with Assessment Technetium 99m Ec20 folate peptide

Data type

boolean

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C4042715

Similar models

Eligibility Ovarian Carcinoma NCT01689714

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Eligibility Criteria Requirement
Item
subjects must meet the following eligibility requirements to be enrolled in the study.
boolean
C1516637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Age
Item
1. subject must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Ovarian Carcinoma | Recurrent Endometrial Cancer | Lesion size | Lesion Quantity | Ultrasonography | Magnetic Resonance Imaging | X-Ray Computed Tomography
Item
2. subject must have known or strongly suspected ovarian carcinoma or recurrent endometrial carcinoma with at least one identifiable lesion > 1.5 cm as diagnosed by ultrasonography, mri, or ct.
boolean
C0029925 (UMLS CUI [1])
C0278802 (UMLS CUI [2])
C0449453 (UMLS CUI [3])
C0221198 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0041618 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0040405 (UMLS CUI [7])
Renal function
Item
3. subject must have good kidney function.
boolean
C0232804 (UMLS CUI [1])
Informed Consent
Item
4. subject must provide written informed consent prior to enrollment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Condition Present
Item
subjects must be excluded if any of the following conditions are present:
boolean
C0348080 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. subject is pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
2. subject is simultaneously participating in another investigational drug study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Clinical Study Follow-up Previous Completed
Item
3. subject has completed the follow-up phase of any previous study less than 30 days prior to enrollment in this study.
boolean
C3274571 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Radionuclide Imaging Receive Unable
Item
4. subject is unable to tolerate conditions for radionuclide imaging.
boolean
C0034606 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Radiopharmaceutical Interferes with Assessment Technetium 99m Ec20 folate peptide
Item
5. subject has been administered another radiopharmaceutical that would interfere with the assessment of technetium tc 99m ec20.
boolean
C0182638 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C4042715 (UMLS CUI [1,4])

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