Hepatocellular Carcinoma
Conditions
Keywords
Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases
Brief summary
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Detailed description
Every patient being treated with TheraSphere needs to have a screening procedure with the administration of a radioactive product named Tc-99m MAA (called pre-treatment mapping). This screening procedure aims to determine if the patient can be treated with TheraSphere. The purpose of this study is to better understand the dose of radiation that is absorbed by the body and the risk of Tc-99m MAA to the whole body and other organs around the liver. The study will determine the amount of Tc-99m MAA that stays in the body and organs up to 24 hours after the administration.
Interventions
DEVICETechnetium-99m macroaggregated albumin (Tc-99m MAA)
Patients who are being evaluated for TheraSphere administration.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Inclusion criteria
1. Patients 21 years and older 2. Written informed consent 3. Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
Exclusion criteria
1. Patients who are contraindicated for TheraSphere treatment. 2. Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert. 3. Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivered Activity of Tc-99m MAA (MBq) for Whole Body | Immediately following | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body. |
| Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | Immediately following | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. |
| Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs. | 4 hours +/- 2 hours | To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs. |
| Delivered Activity of Tc-99m MAA (MBq) for Whole Body. | 18-24 hours | To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection. |
| Absorbed Dose of Tc-99m MAA (mGy) for Whole Body. | Overall | To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body. |
| Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs | Overall | To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs. |
| Effective Dose of Tc-99m MAA (mSv) Whole Body | Overall | To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs. |
| Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body | Overall | To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body. |
| Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs | Overall | To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at one clinical study site, NWU in Chicago, IL USA. Six patients consented and enrolled. Patient considered enrolled at time of consent per protocol. Patient 001 withdrew consent prior to the Tc-99m MAA procedure. Five patients received protocol required imaging after Tc-99m MAA injections. Patient # Date of Enrollment: 1. Apr 4, 2022 2. Feb 4, 2023 3. Mar 4, 2023 4. Mar 14, 2023 5. May 10, 2023 6. Jun 6, 2023
Participants by arm
| Arm | Count |
|---|---|
| Clinical Cohort Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection.
Technetium-99m macroaggregated albumin (Tc-99m MAA): Patients who are being evaluated for TheraSphere administration. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Clinical Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Participants. Female | 1 Participants |
| Sex: Female, Male Participants. Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall
Population: Patient who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs | 4.812 mGy |
Primary
Absorbed Dose of Tc-99m MAA (mGy) for Whole Body.
To provide imaging data calculating radiation-absorbed dose of Tc-99m MAA to the whole body.
Time frame: Overall
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Absorbed Dose of Tc-99m MAA (mGy) for Whole Body. | 10.970 mGy |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Time frame: Immediately following
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | 6.986 MBq |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
To provide imaging data to calculate radiation delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Time frame: 18-24 hours
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs | 0.662 MBq |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs.
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Time frame: 4 hours +/- 2 hours
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs. | 8.640 MBq |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body.
Time frame: 4 hours +/- 2 hours
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Whole Body | 27.978 MBq |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Whole Body
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
Time frame: Immediately following
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Whole Body | 67.322 MBq |
Primary
Delivered Activity of Tc-99m MAA (MBq) for Whole Body.
To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body following injection.
Time frame: 18-24 hours
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Delivered Activity of Tc-99m MAA (MBq) for Whole Body. | 1.694 MBq |
Primary
Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body
To provide data calculating radiation-effective dose of Tc-99m MAA to Whole Body.
Time frame: Overall
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clinical Cohort | Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body | 0.008 mSv/mBq |
Primary
Effective Dose of Tc-99m MAA (mSv) Whole Body
To provide imaging data calculating radiation-effective does of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Effective Dose of Tc-99m MAA (mSv) Whole Body | 0.666 mSv |
Primary
Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs
To provide imaging data calculating radiation-equivalent dose of Tc-99m MAA to Non-Liver Critical Organs.
Time frame: Overall
Population: Patients who are being evaluated for TheraSphere administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinical Cohort | Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs | 0.384 mSv |