ID

38242

Description

Positron Emission Mammography With Fluorothymidine (FLT) to Evaluate Treatment Response to Chemotherapy in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00934401

Link

https://clinicaltrials.gov/show/NCT00934401

Keywords

Versions (1)
  1. 10/1/19 10/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00934401

English

Eligibility Breast Neoplasms NCT00934401

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to understand and willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. subject must have histologically confirmed breast cancer.
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
3. subject must be scheduled to receive neoadjuvant chemotherapy followed by surgery for their standard cancer care. treatment decisions will be made by the treating surgeon and the medical oncologist.
Description

Neoadjuvant Chemotherapy Scheduled | Secondly Operative Surgical Procedure Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0205436
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0205539
4. females at least 18 years of age.
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
5. karnofsky at least 60% at time of screening.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
6. life expectancy of greater than 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
leukocytes at least 3,000/microl
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count at least 1,500/microl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets at least 100,000/microl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin equal or less than 1.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast(sgot) no greater than 2.5 x institutional upper limit of normal
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
alt (sgpt) no greater than 2.5 x institutional upper limit of normal
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
creatinine equal or less than 1.4 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
bun equal or less than 20 mg /dl
Description

Blood urea nitrogen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0005845
8. the effects of flt on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a screening urine hcg will be administered in the nuclear medicine to women of childbearing potential before each flt scan and pregnant women will not be accepted as subjects in this study.
Description

Effects of FLT Fetus Unknown | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C1704420
UMLS CUI [1,2]
C0206795
UMLS CUI [1,3]
C0015965
UMLS CUI [1,4]
C0439673
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Description

Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse event Due to Pharmaceutical Preparations | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0013227
UMLS CUI [6,1]
C2004454
UMLS CUI [6,2]
C0332268
2. subject with a karnofsky score of below 60.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
3. pregnant women are excluded from this study. flt pet has potential for teratogenic effects. because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with flt, breastfeeding should be discontinued if the mother is imaged with flt and may not resume for 48 hours after the flt imaging.
Description

Pregnancy | Breast Feeding To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1272691
4. subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Description

Nucleoside Analogs | Anti-Retroviral Agents

Data type

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0599685
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Similar models

Eligibility Breast Neoplasms NCT00934401

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. ability to understand and willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. subject must have histologically confirmed breast cancer.
boolean
C0678222 (UMLS CUI [1])
Neoadjuvant Chemotherapy Scheduled | Secondly Operative Surgical Procedure Scheduled
Item
3. subject must be scheduled to receive neoadjuvant chemotherapy followed by surgery for their standard cancer care. treatment decisions will be made by the treating surgeon and the medical oncologist.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0205436 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Gender | Age
Item
4. females at least 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Karnofsky Performance Status
Item
5. karnofsky at least 60% at time of screening.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
7. subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
leukocytes at least 3,000/microl
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count at least 1,500/microl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets at least 100,000/microl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin equal or less than 1.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast(sgot) no greater than 2.5 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt (sgpt) no greater than 2.5 x institutional upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine equal or less than 1.4 mg/dl
boolean
C0201976 (UMLS CUI [1])
Blood urea nitrogen measurement
Item
bun equal or less than 20 mg /dl
boolean
C0005845 (UMLS CUI [1])
Effects of FLT Fetus Unknown | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
8. the effects of flt on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. a screening urine hcg will be administered in the nuclear medicine to women of childbearing potential before each flt scan and pregnant women will not be accepted as subjects in this study.
boolean
C1704420 (UMLS CUI [1,1])
C0206795 (UMLS CUI [1,2])
C0015965 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse event Due to Pharmaceutical Preparations | Recovery Lacking
Item
1. subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C2004454 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
Karnofsky Performance Status
Item
2. subject with a karnofsky score of below 60.
boolean
C0206065 (UMLS CUI [1])
Pregnancy | Breast Feeding To be stopped
Item
3. pregnant women are excluded from this study. flt pet has potential for teratogenic effects. because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with flt, breastfeeding should be discontinued if the mother is imaged with flt and may not resume for 48 hours after the flt imaging.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Nucleoside Analogs | Anti-Retroviral Agents
Item
4. subjects taking nucleoside analog medications such as those used as antiretroviral agents.
boolean
C1579410 (UMLS CUI [1])
C0599685 (UMLS CUI [2])
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