Clinical trial NCT03896646: Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
Official title: Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stage III Hepatocellular Carcinoma AJCC v8
Stage IIIA Hepatocellular Carcinoma AJCC v8
Stage IIIB Hepatocellular Carcinoma AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8
Stage IVA Hepatocellular Carcinoma AJCC v8
Stage IVB Hepatocellular Carcinoma AJCC v8
Unresectable Hepatocellular Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To achieve tumor objective response rates of 75% using voxel based dosimetry when the mean dose (Dmean) to tumor is targeted to be greater than 200 Gray (Gy).

SECONDARY OBJECTIVES:

I. Correlate changes in liver function and Common Terminology Criteria for Adverse Events (CTCAE) incidence to the mean absorbed dose to normal liver.

II. Prospectively validate the accuracy of our published tumor dose response prediction based on the yttrium Y 90 glass microspheres (yttrium-90 \[Y90\]) tumor dose volume histograms (DVHs).

III. Correlate predicted tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan).

IV. Develop a tumor dose response model prediction based on the MAA dose maps. V. Develop a model correlating normal liver radiation dose to liver function using single-photon emission computed tomography/computed tomography hepatobiliary iminodiacetic acid (SPECT/CT HIDA) imaging.

VI. Develop a model correlating the relative tumor to normal liver enhancement on CT imaging and Cone beam CT imaging to the uptake on SPECT CT Tc99m MAA imaging (gold standard).

VII. Compare tumor and normal liver doses estimations from SPECT CT Bremsstrahlung imaging to positron emission tomography (PET) CT imaging.

OUTLINE:

Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization.

After completion of study treatment, patients are followed up at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \</=2, with a life expectancy of \>/=3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least one month post chemotherapy.
2. At least one lesion \>/= 3.0 cm in shortest dimension
3. AST or ALT \<5 times ULN
4. Bilirubin \</= 2.0 mg/dL (unless segmental infusion is used)
5. Negative pregnancy test in premenopausal women

Exclusion Criteria:

1. Contraindications to angiography and selective visceral catheterization
2. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) to the lungs with a single injection, or greater than 50 Gy for multiple injections
3. Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
4. Significant extrahepatic disease representing an imminent life-threatening outcome
5. Severe liver dysfunction or pulmonary insufficiency
6. Active uncontrolled infection
7. Significant underlying medical or psychiatric illness
8. Pregnant
9. Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk
10. Infiltrative tumors

Primary outcomes:
measure: Tumor objective response rate (ORR)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Changes in liver function
timeFrame: Up to 6 months
measure: Changes in Common Terminology Criteria for Adverse Events (CTCAE) incidence
timeFrame: Up to 6 months
measure: Accuracy of published tumor dose response prediction based on the yttrium-90 (Y90) tumor dose volume histograms
timeFrame: Up to 6 months
measure: Prediction of tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan)
timeFrame: Up to 6 months
measure: Development of tumor dose response model prediction based on MAA dose maps
timeFrame: Up to 6 months
measure: Development of a model correlating normal liver radiation dose to liver function using single-photon emission computed tomography computed tomography hepatobiliary iminodiacetic acid (SPECT CT HIDA) imaging
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Armeen Mahvash
role: PRINCIPAL_INVESTIGATOR
References: