Liver CancerNCT03338062
A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy
A study testing Hepatobiliary Iminodiacetic Acid (HIDA) scan in people with Liver Cancer and Hepatocellular Carcinoma, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma
- What is being tested?
- Hepatobiliary Iminodiacetic Acid (HIDA) scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 2 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be ≥ 18 years of age at the time of signing informed consent
- Diagnosis of primary liver malignancy (including hepatocellular carcinoma [HCC] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
- Subjects with other current or prior malignancies are eligible for this study.
- Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:
- History of liver resection (at any time)
- History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency due to any cause
Show all 12Show fewer
- Prior radiation to the upper abdomen including radioembolization
- ECOG (Zubrod) Performance Status 0-2.
- Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.
- Patients who have been previously treated with non-SBRT liver directed therapies may be enrolled on study. At least 3 months must have elapsed between the most recent liver-directed therapy and study entry.
- Ability to provide written informed consent and HIPAA authorization
- Subjects with an allergy to contrast agents may be enrolled at the treating physician's discretion with appropriate pre-treatment and symptom management.
Who cannot join
- Subjects who are pregnant or planning to become pregnant during the study. Women of child bearing potential must have a negative pregnancy test
- Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.
- No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the lesion(s) must be ≤6 cm
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in the opinion of the investigator limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma
- Being tested
- Hepatobiliary Iminodiacetic Acid (HIDA) scan
- Keywords
- Radiation Treatment
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatobiliary Iminodiacetic Acid (HIDA) scanDiagnostic test
HIDA scan was used as the planning scan for SBRT.
| Study group | Role | What they receive |
|---|---|---|
| Theragnostic SBRT Planning | Experimental | The theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. Receives: Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scan |
| Standard SBRT Planning | No intervention | The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen.
Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient.
Measured: Day -1 of Radiation Treatment
Secondary outcomes (9)
Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan
The percentage of participants for whom theragnostically planned radiation is chosen for the radiation treatment plan over the standard plan will be calculated along with the corresponding exact 95% Binomial confidence interval.
Measured: Day -1 of Radiation Treatment
Duration of Local Control
Duration of local control was assessed by calculating the time from on study date to date of local failure. Patients who did not experience local failure were censored at their last evaluation date. Local failure (progressive disease at primary diagnosis site) was evaluated using RECIST v1.1 criteria:
Complete response: Disappearance of all target lesions; Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 15 months
Progression Free Survival
Progression free survival was defined as the time from on study date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 15 months
Overall Survival
Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 3 years
Time to Transplant
Time to transplant was defined as the time from on study date to the date of transplant. Patients who did not receive transplant were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 15 months
Time to Distant Liver Failure
Time to distant liver failure was defined as the time from on study date to the date of distant liver failure. Patients who did not experience distant liver failure were censored at their date of last evaluation. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 15 months
Time Until Salvage Treatment
Time until salvage treatment was defined as the time from on study date to the start date of salvage treatment. Patients who did not receive salvage treatment were censored at their off study date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Measured: Up to 15 months
Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Every 15 days for approximately 6 months
Change in MELD Score
Model for end-stage liver disease (MELD) score measures the severity of liver dysfunction. MELD scores range from 6 to 40 and are based on lab tests including serum creatinine, total bilirubin, and INR. The higher the number, the worse the liver function.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start13 Jun 2017
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Rhome,, Indiana University
- Investigators
- Ryan M Rhome, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338062
- Sponsor's protocol ID
- IUSCC-0604
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2017
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
- ClinicalTrials.gov ID
- NCT03338062
- Acronym / sponsor ID
- IUSCC-0604
- Conditions
- Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma
- Keywords
- Radiation Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theragnostic SBRT Planning | Experimental | Diagnostic Test: Hepatobiliary Iminodiacetic Acid (HIDA) scanThe theragnostic SBRT plan using the HIDA scan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
| Standard SBRT Planning | No intervention | –The standard SBRT plan was chosen as the plan that reduced the dose of radiation to functional liver without compromising target coverage or tumor control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must be ≥ 18 years of age at the time of signing informed consent
- Diagnosis of primary liver malignancy (including hepatocellular carcinoma [HCC] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
- Subjects with other current or prior malignancies are eligible for this study.
- Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:
- ECOG (Zubrod) Performance Status 0-2.
Key exclusion criteria (4 listed)
- Subjects who are pregnant or planning to become pregnant during the study. Women of child bearing potential must have a negative pregnancy test
- Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.
- No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the lesion(s) must be ≤6 cm
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in the opinion of the investigator limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatobiliary Iminodiacetic Acid (HIDA) scanHIDA scan was used as the planning scan for SBRT. | Diagnostic test | Theragnostic SBRT Planning |
Primary outcome
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
Time frame: Day -1 of Radiation Treatment
The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient.
9 secondary outcomes
Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan
Time frame: Day -1 of Radiation Treatment
Duration of Local Control
Time frame: Up to 15 months
Progression Free Survival
Time frame: Up to 15 months
Overall Survival
Time frame: Up to 3 years
Time to Transplant
Time frame: Up to 15 months
Time to Distant Liver Failure
Time frame: Up to 15 months
Time Until Salvage Treatment
Time frame: Up to 15 months
Number of Patients With Treatment-Related Adverse Events Grade 3 or Above
Time frame: Every 15 days for approximately 6 months
Change in MELD Score
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan M Rhome, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatobiliary Iminodiacetic Acid (HIDA) scan in people with Liver Cancer and Hepatocellular Carcinoma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning (time frame: Day -1 of Radiation Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.