ID

39343

Description

Imaging Study for FdCyd and THU Cancer Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01479348

Link

https://clinicaltrials.gov/show/NCT01479348

Keywords

Versions (1)
  1. 12/23/19 12/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Neoplasms NCT01479348

English

Eligibility Head and Neck Neoplasms NCT01479348

1 forms  
Criteria
Description

Criteria

enrolled in the nih phase ii clinical protocol evaluating fdcyd with thu (09-c-0214) with target lesion measured as greater than or equal to 10mm with spiral ct scan.
Description

Study Subject Participation Status Clinical Trial Specified | FdCyd | THU | Target Lesion Size Spiral CT

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C0049174
UMLS CUI [3]
C0039677
UMLS CUI [4,1]
C2986546
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0860888
written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
for females: negative serum pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
Description

Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with severe claustrophobia unresponsive to oral anxiolytics
Description

Claustrophobia Severe | Unresponsive to Anti-Anxiety Agents Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0040616
UMLS CUI [2,3]
C1527415
subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry
Description

Body Weight | Body Weight Inappropriate Scanner | Study Subject Inappropriate Imaging Technique

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C1710020
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0079595
known allergy to fdcyd
Description

Hypersensitivity FdCyd

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0049174
the subject is unable to lie still for 75 minutes
Description

Lacking Able to lie down Quiet Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0439654
UMLS CUI [1,4]
C0449238
5 pregnant or lactating women. pregnant women are excluded from this study because the effects of 18f-fdcyd in pregnancy are not known. because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18ffdcyd in the mother, breastfeeding should be discontinued if the mother receives 18ffdcyd
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
Description

Medical condition Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Medical condition Interferes with Research results | Mental condition Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0184661
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
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Similar models

Eligibility Head and Neck Neoplasms NCT01479348

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Subject Participation Status Clinical Trial Specified | FdCyd | THU | Target Lesion Size Spiral CT
Item
enrolled in the nih phase ii clinical protocol evaluating fdcyd with thu (09-c-0214) with target lesion measured as greater than or equal to 10mm with spiral ct scan.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0049174 (UMLS CUI [2])
C0039677 (UMLS CUI [3])
C2986546 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])
Informed Consent
Item
written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Gender Serum pregnancy test negative | Postmenopausal state | Hysterectomy
Item
for females: negative serum pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy
boolean
C0079399 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Claustrophobia Severe | Unresponsive to Anti-Anxiety Agents Oral
Item
participants with severe claustrophobia unresponsive to oral anxiolytics
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0040616 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Body Weight | Body Weight Inappropriate Scanner | Study Subject Inappropriate Imaging Technique
Item
subjects weighing > 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry
boolean
C0005910 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C1710020 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0079595 (UMLS CUI [3,3])
Hypersensitivity FdCyd
Item
known allergy to fdcyd
boolean
C0020517 (UMLS CUI [1,1])
C0049174 (UMLS CUI [1,2])
Lacking Able to lie down Quiet Duration
Item
the subject is unable to lie still for 75 minutes
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0439654 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
5 pregnant or lactating women. pregnant women are excluded from this study because the effects of 18f-fdcyd in pregnancy are not known. because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18ffdcyd in the mother, breastfeeding should be discontinued if the mother receives 18ffdcyd
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Interferes with Interventional procedure | Mental condition Interferes with Interventional procedure | Medical condition Interferes with Research results | Mental condition Interferes with Research results
Item
participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
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