ID

32463

Description

Fluorine F 18 EF5 Positron Emission Tomography in Assessing Hypoxia in Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Head or Neck Squamous Cell Cancer of the Oral Cavity, Oropharynx, and Larynx; ODM derived from: https://clinicaltrials.gov/show/NCT01020097

Link

https://clinicaltrials.gov/show/NCT01020097

Keywords

Versions (1)
  1. 11/2/18 11/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT01020097

English

Eligibility Squamous Cell Carcinoma NCT01020097

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologically confirmed and/or clinical and imaging evidence of a stage 1-4 de novo mass in the larynx, pharynx or oral cavity
Description

Tumor Mass de novo Larynx TNM clinical staging | Tumor Mass de novo Pharynx TNM clinical staging | Tumor Mass de novo Oral cavity TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0023078
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C1515568
UMLS CUI [2,3]
C0031354
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C3273930
UMLS CUI [3,2]
C1515568
UMLS CUI [3,3]
C0226896
UMLS CUI [3,4]
C3258246
treatment plan should include surgery (biopsy or excision) and may be followed by radiation and/ or concurrent chemotherapy
Description

Treatment Plan Including Operative Surgical Procedures | Biopsy | Excision | Treatment Plan Including Therapeutic radiology procedure | Treatment Plan Including Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0599880
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0543467
UMLS CUI [2]
C0005558
UMLS CUI [3]
C0728940
UMLS CUI [4,1]
C0599880
UMLS CUI [4,2]
C0332257
UMLS CUI [4,3]
C1522449
UMLS CUI [5,1]
C0599880
UMLS CUI [5,2]
C0332257
UMLS CUI [5,3]
C0392920
patients' disease must not require emergency surgical attention
Description

Requirement Absent Emergency surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4264510
the need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
Description

Patient need for Tracheotomy | Patient need for FEEDING TUBE INSERTION

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0040591
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0743847
patients must have a karnofsky performance status >= 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
Description

Patient condition Standard therapy Surgical biopsy | Patient condition Standard therapy Excision

Data type

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0565118
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C0728940
patients must have normal organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
wbc > 2,000/mm^3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
platelets > 100,000/mm^3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Description

Pregnancy | Pregnancy Suspected | Treating Physician Informed

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1710470
UMLS CUI [3,2]
C1522154
serum pregnancy testing will be required for women of childbearing age
Description

Childbearing Potential Serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430064
ability to understand and the willingness to sign a written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5
Description

Allergic Reaction Flagyl | Allergic Reaction Metronidazole

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0699678
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0025872
uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Description

Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
pregnant women and women who are breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients whose clinical status requires that surgery for their hnscc be performed emergently or in a time course that does not allow scheduling of an 18f-ef5 pet scan preceding surgery and chemoradiation
Description

Clinical status Requirement Emergency surgery | SCCHN | F 18 EF5 PET scan Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0449440
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C4264510
UMLS CUI [2]
C1168401
UMLS CUI [3,1]
C1541539
UMLS CUI [3,2]
C0032743
UMLS CUI [3,3]
C0332196
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Similar models

Eligibility Squamous Cell Carcinoma NCT01020097

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Tumor Mass de novo Larynx TNM clinical staging | Tumor Mass de novo Pharynx TNM clinical staging | Tumor Mass de novo Oral cavity TNM clinical staging
Item
patients must have a histologically confirmed and/or clinical and imaging evidence of a stage 1-4 de novo mass in the larynx, pharynx or oral cavity
boolean
C3273930 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0023078 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C3273930 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0031354 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C3273930 (UMLS CUI [3,1])
C1515568 (UMLS CUI [3,2])
C0226896 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
Treatment Plan Including Operative Surgical Procedures | Biopsy | Excision | Treatment Plan Including Therapeutic radiology procedure | Treatment Plan Including Chemotherapy
Item
treatment plan should include surgery (biopsy or excision) and may be followed by radiation and/ or concurrent chemotherapy
boolean
C0599880 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2])
C0728940 (UMLS CUI [3])
C0599880 (UMLS CUI [4,1])
C0332257 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C0599880 (UMLS CUI [5,1])
C0332257 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
Requirement Absent Emergency surgery
Item
patients' disease must not require emergency surgical attention
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4264510 (UMLS CUI [1,3])
Patient need for Tracheotomy | Patient need for FEEDING TUBE INSERTION
Item
the need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
boolean
C0686904 (UMLS CUI [1,1])
C0040591 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0743847 (UMLS CUI [2,2])
Karnofsky Performance Status
Item
patients must have a karnofsky performance status >= 70
boolean
C0206065 (UMLS CUI [1])
Patient condition Standard therapy Surgical biopsy | Patient condition Standard therapy Excision
Item
patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
boolean
C0683521 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0565118 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
wbc > 2,000/mm^3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelets > 100,000/mm^3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier
Item
women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
Pregnancy | Pregnancy Suspected | Treating Physician Informed
Item
should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1710470 (UMLS CUI [3,1])
C1522154 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test
Item
serum pregnancy testing will be required for women of childbearing age
boolean
C3831118 (UMLS CUI [1,1])
C0430064 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Flagyl | Allergic Reaction Metronidazole
Item
history of allergic reactions attributed to flagyl (metronidazole), which has a chemical structure similar to ef5
boolean
C1527304 (UMLS CUI [1,1])
C0699678 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0025872 (UMLS CUI [2,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant women and women who are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Clinical status Requirement Emergency surgery | SCCHN | F 18 EF5 PET scan Excluded
Item
patients whose clinical status requires that surgery for their hnscc be performed emergently or in a time course that does not allow scheduling of an 18f-ef5 pet scan preceding surgery and chemoradiation
boolean
C0449440 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4264510 (UMLS CUI [1,3])
C1168401 (UMLS CUI [2])
C1541539 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
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