ID

38607

Description

Humanitarian Device Exemption (HDE) Treatment Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT01176604

Link

https://clinicaltrials.gov/show/NCT01176604

Keywords

Versions (1)
  1. 10/27/19 10/27/19 -
Copyright Holder

See clinicaltrials.gov

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October 27, 2019

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Hepatocellular NCT01176604

English

Eligibility Carcinoma, Hepatocellular NCT01176604

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of unresectable intrahepatic hcc. the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (afp)^21 and clinical findings. guidelines from the american association for the study of liver diseases (aasld) and the european association for the study of the liver (easl) describe in detail the approach and algorithm for diagnosing hcc.
Description

Liver carcinoma intrahepatic unresectable | Liver mass Identifiable Radiography | Risk factors Known Malignant Neoplasm | Tumour marker increased | Other Coding | alpha-Fetoprotein | Clinical findings

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1512948
UMLS CUI [1,3]
C1519810
UMLS CUI [2,1]
C0240225
UMLS CUI [2,2]
C0205396
UMLS CUI [2,3]
C0034571
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C0205309
UMLS CUI [3,3]
C0006826
UMLS CUI [4]
C0876999
UMLS CUI [5]
C3846158
UMLS CUI [6]
C0002210
UMLS CUI [7]
C0037088
2. eastern cooperative oncology group (ecog) performance status score 0 - 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. life expectancy >/= 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
4. > 4 weeks since prior radiation, surgery or chemotherapy
Description

Prior radiation therapy | Prior surgery | Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C0455610
UMLS CUI [3]
C1514457
5. able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction: • ast (serum glutamic-oxalacetic transaminase - sgot) or alt (serum glutamic-pyruvic transaminase - sgpt) > 5 times upper normal limit (unl) • serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Description

Liver Dysfunction Laboratory test finding Pretreatment | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum total bilirubin measurement | Exception Infusion Segmental Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C3539076
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C1278039
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0574032
UMLS CUI [5,3]
C0205122
UMLS CUI [5,4]
C1301732
2. any contraindications to angiography and hepatic artery catheterization such as: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated; bleeding diathesis, not correctable by usual forms of therapy; severe peripheral vascular disease that would preclude catheterization.
Description

Medical contraindication Angiography | Medical contraindication Catheterization hepatic artery | Contrast media allergy Severe | Intolerance to Contrast Media | Narcotic allergy Severe | Intolerance to Narcotics | Sedative allergy Severe | Intolerance to Sedatives | Atropine allergy Severe | Intolerance to Atropine | Bleeding tendency | Peripheral Vascular Disease Severe Excludes Catheterization

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0002978
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C4031927
UMLS CUI [3,1]
C0570562
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0009924
UMLS CUI [5,1]
C0746753
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0027415
UMLS CUI [7,1]
C0570793
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0036557
UMLS CUI [9,1]
C0570993
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0004259
UMLS CUI [11]
C1458140
UMLS CUI [12,1]
C0085096
UMLS CUI [12,2]
C0205082
UMLS CUI [12,3]
C0332196
UMLS CUI [12,4]
C0007430
3. evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs in a single treatment
Description

Irradiation of lung Dose Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C2169076
UMLS CUI [1,2]
C0034524
UMLS CUI [1,3]
C0087111
4. clinical evidence of pulmonary insufficiency
Description

Pulmonary Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0034088
5. evidence of any detectable technetium-99 macroaggregated albumin (tc-99m maa) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
Description

Tc 99m MAA Flow Stomach | Tc 99m MAA Flow Duodenum

Data type

boolean

Alias
UMLS CUI [1,1]
C0039415
UMLS CUI [1,2]
C0806140
UMLS CUI [1,3]
C0038351
UMLS CUI [2,1]
C0039415
UMLS CUI [2,2]
C0806140
UMLS CUI [2,3]
C0013303
6. complete occlusion of the main portal vein.
Description

Complete obstruction Main portal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0001168
UMLS CUI [1,2]
C1183135
7. significant extrahepatic disease representing an imminent life-threatening outcome
Description

Disease Extrahepatic | Outcome Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517058
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C2826244
8. active uncontrolled infection.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
9. significant underlying medical or psychiatric illness.
Description

Illness Significant | Mental disorder Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
10. co-morbid disease of condition that would preclude safe delivery of therasphere treatment or, in the judgment of the physician, place the patient at undue risk
Description

Comorbidity Excludes Therasphere | Comorbidity At risk Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1135147
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
11. pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
12. tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dl, or complete occlusion of the main portal vein.
Description

Tumor type Infiltrating Imaging | Tumor % volume Liver | Tumor Nodule Numerous | Albumin measurement | Complete obstruction Main portal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C4263544
UMLS CUI [1,2]
C0332448
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1690016
UMLS CUI [2,3]
C0023884
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0028259
UMLS CUI [3,3]
C0439064
UMLS CUI [4]
C0201838
UMLS CUI [5,1]
C0001168
UMLS CUI [5,2]
C1183135
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Similar models

Eligibility Carcinoma, Hepatocellular NCT01176604

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma intrahepatic unresectable | Liver mass Identifiable Radiography | Risk factors Known Malignant Neoplasm | Tumour marker increased | Other Coding | alpha-Fetoprotein | Clinical findings
Item
1. diagnosis of unresectable intrahepatic hcc. the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (afp)^21 and clinical findings. guidelines from the american association for the study of liver diseases (aasld) and the european association for the study of the liver (easl) describe in detail the approach and algorithm for diagnosing hcc.
boolean
C2239176 (UMLS CUI [1,1])
C1512948 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C0240225 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0035648 (UMLS CUI [3,1])
C0205309 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0876999 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0002210 (UMLS CUI [6])
C0037088 (UMLS CUI [7])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance status score 0 - 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy >/= 3 months
boolean
C0023671 (UMLS CUI [1])
Prior radiation therapy | Prior surgery | Prior Chemotherapy
Item
4. > 4 weeks since prior radiation, surgery or chemotherapy
boolean
C0279134 (UMLS CUI [1])
C0455610 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
Informed Consent
Item
5. able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction Laboratory test finding Pretreatment | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum total bilirubin measurement | Exception Infusion Segmental Planned
Item
1. any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction: • ast (serum glutamic-oxalacetic transaminase - sgot) or alt (serum glutamic-pyruvic transaminase - sgpt) > 5 times upper normal limit (unl) • serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
boolean
C0086565 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C3539076 (UMLS CUI [1,3])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0574032 (UMLS CUI [5,2])
C0205122 (UMLS CUI [5,3])
C1301732 (UMLS CUI [5,4])
Medical contraindication Angiography | Medical contraindication Catheterization hepatic artery | Contrast media allergy Severe | Intolerance to Contrast Media | Narcotic allergy Severe | Intolerance to Narcotics | Sedative allergy Severe | Intolerance to Sedatives | Atropine allergy Severe | Intolerance to Atropine | Bleeding tendency | Peripheral Vascular Disease Severe Excludes Catheterization
Item
2. any contraindications to angiography and hepatic artery catheterization such as: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated; bleeding diathesis, not correctable by usual forms of therapy; severe peripheral vascular disease that would preclude catheterization.
boolean
C1301624 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C4031927 (UMLS CUI [2,2])
C0570562 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0009924 (UMLS CUI [4,2])
C0746753 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0027415 (UMLS CUI [6,2])
C0570793 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0036557 (UMLS CUI [8,2])
C0570993 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0004259 (UMLS CUI [10,2])
C1458140 (UMLS CUI [11])
C0085096 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0332196 (UMLS CUI [12,3])
C0007430 (UMLS CUI [12,4])
Irradiation of lung Dose Treatment
Item
3. evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs in a single treatment
boolean
C2169076 (UMLS CUI [1,1])
C0034524 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Pulmonary Insufficiency
Item
4. clinical evidence of pulmonary insufficiency
boolean
C0034088 (UMLS CUI [1])
Tc 99m MAA Flow Stomach | Tc 99m MAA Flow Duodenum
Item
5. evidence of any detectable technetium-99 macroaggregated albumin (tc-99m maa) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
boolean
C0039415 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
C0038351 (UMLS CUI [1,3])
C0039415 (UMLS CUI [2,1])
C0806140 (UMLS CUI [2,2])
C0013303 (UMLS CUI [2,3])
Complete obstruction Main portal vein
Item
6. complete occlusion of the main portal vein.
boolean
C0001168 (UMLS CUI [1,1])
C1183135 (UMLS CUI [1,2])
Disease Extrahepatic | Outcome Life Threatening
Item
7. significant extrahepatic disease representing an imminent life-threatening outcome
boolean
C0012634 (UMLS CUI [1,1])
C1517058 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
8. active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Illness Significant | Mental disorder Significant
Item
9. significant underlying medical or psychiatric illness.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Comorbidity Excludes Therasphere | Comorbidity At risk Patient
Item
10. co-morbid disease of condition that would preclude safe delivery of therasphere treatment or, in the judgment of the physician, place the patient at undue risk
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1135147 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
Pregnancy
Item
11. pregnancy
boolean
C0032961 (UMLS CUI [1])
Tumor type Infiltrating Imaging | Tumor % volume Liver | Tumor Nodule Numerous | Albumin measurement | Complete obstruction Main portal vein
Item
12. tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dl, or complete occlusion of the main portal vein.
boolean
C4263544 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1690016 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C0028259 (UMLS CUI [3,2])
C0439064 (UMLS CUI [3,3])
C0201838 (UMLS CUI [4])
C0001168 (UMLS CUI [5,1])
C1183135 (UMLS CUI [5,2])
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