Dataset Information

Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial.

ABSTRACT:

Purpose

To compare the accuracy and safety of 0.56 GBq resin yttrium-90 (⁹⁰Y) (scout⁹⁰Y) microspheres with those of technetium-99m macroaggregated albumin (MAA) in predicting the therapeutic ⁹⁰Y (Rx⁹⁰Y) dose for patients with hepatocellular carcinoma (HCC).

Materials and methods

This prospective single-arm clinical trial (Clinicaltrials.gov: NCT04172714) recruited patients with HCC. Patients underwent same-day mapping with MAA and scout⁹⁰Y. Rx⁹⁰Y activity was administered 3 days after mapping. Using paired t test and Pearson correlation, the tumor-to-normal ratio (TNR), lung shunt fraction (LSF), predicted mean tumor dose (TD), and nontumoral liver dose (NTLD) by MAA and scout⁹⁰Y were compared with those by Rx⁹⁰Y. Bland-Altman plots compared the level of agreement between the TNR and LSF of scout⁹⁰Y and MAA with that of Rx⁹⁰Y. The safety of scout⁹⁰Y was evaluated by examining the discrepancy in extrahepatic activity between MAA and scout⁹⁰Y.

Results

Thirty patients were treated using 19 segmental and 14 nonsegmental (ie, 2 contiguous segments or nonsegmental) therapies. MAA had weak LSF, moderate TNR, and moderate TD linear correlation with Rx⁹⁰Y. Scout⁹⁰Y had a moderate LSF, strong TNR, strong TD, and very strong NTLD in correlation with those of Rx⁹⁰Y. Furthermore, the TNR and LSF of scout⁹⁰Y had a stronger agreement with those of Rx⁹⁰Y than with those of MAA. In the nonsegmental subgroup, MAA had no significant correlation with the TD and NTLD of Rx⁹⁰Y, whereas scout⁹⁰Y had a very strong correlation with both of these factors. In the segmental subgroup, both MAA and scout⁹⁰Y had a strong linear correlation with the TD and NTLD of Rx⁹⁰Y.

Conclusions

Compared with MAA, scout⁹⁰Y is a more accurate surrogate for Rx⁹⁰Y biodistribution for nonsegmental therapies.

SUBMITTER: Kokabi N

PROVIDER: S-EPMC9834905 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial.

Kokabi Nima N Webster Linzi A LA Elsayed Mohammad M Switchenko Jeffrey M JM Chen Bernard B Brandon David D Galt James J Sethi Ila I Cristescu Mircea M Kappadath S Cheenu SC Schuster David M DM

Journal of vascular and interventional radiology : JVIR 20220906 12

<h4>Purpose</h4>To compare the accuracy and safety of 0.56 GBq resin yttrium-90 (<sup>90</sup>Y) (scout<sup>90</sup>Y) microspheres with those of technetium-99m macroaggregated albumin (MAA) in predicting the therapeutic <sup>90</sup>Y (Rx<sup>90</sup>Y) dose for patients with hepatocellular carcinoma (HCC).<h4>Materials and methods</h4>This prospective single-arm clinical trial (Clinicaltrials.gov: NCT04172714) recruited patients with HCC. Patients underwent same-day mapping with MAA and scout< ...[more]

PMID: 36075560

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Project description:BackgroundCoincidence imaging of low-abundance yttrium-90 (90Y) internal pair production by positron emission tomography with integrated computed tomography (PET/CT) achieves high-resolution imaging of post-radioembolization microsphere biodistribution. Part 2 analyzes tumor and non-target tissue dose-response by 90Y PET quantification and evaluates the accuracy of tumor 99mTc macroaggregated albumin (MAA) single-photon emission computed tomography with integrated CT (SPECT/CT) predictive dosimetry.MethodsRetrospective dose quantification of 90Y resin microspheres was performed on the same 23-patient data set in part 1. Phantom studies were performed to assure quantitative accuracy of our time-of-flight lutetium-yttrium-oxyorthosilicate system. Dose-responses were analyzed using 90Y dose-volume histograms (DVHs) by PET voxel dosimetry or mean absorbed doses by Medical Internal Radiation Dose macrodosimetry, correlated to follow-up imaging or clinical findings. Intended tumor mean doses by predictive dosimetry were compared to doses by 90Y PET.ResultsPhantom studies demonstrated near-perfect detector linearity and high tumor quantitative accuracy. For hepatocellular carcinomas, complete responses were generally achieved at D70 > 100 Gy (D70, minimum dose to 70% tumor volume), whereas incomplete responses were generally at D70 < 100 Gy; smaller tumors (<80 cm3) achieved D70 > 100 Gy more easily than larger tumors. There was complete response in a cholangiocarcinoma at D70 90 Gy and partial response in an adrenal gastrointestinal stromal tumor metastasis at D70 53 Gy. In two patients, a mean dose of 18 Gy to the stomach was asymptomatic, 49 Gy caused gastritis, 65 Gy caused ulceration, and 53 Gy caused duodenitis. In one patient, a bilateral kidney mean dose of 9 Gy (V20 8%) did not cause clinically relevant nephrotoxicity. Under near-ideal dosimetric conditions, there was excellent correlation between intended tumor mean doses by predictive dosimetry and those by 90Y PET, with a low median relative error of +3.8% (95% confidence interval, -1.2% to +13.2%).ConclusionsTumor and non-target tissue absorbed dose quantification by 90Y PET is accurate and yields radiobiologically meaningful dose-response information to guide adjuvant or mitigative action. Tumor 99mTc MAA SPECT/CT predictive dosimetry is feasible. 90Y DVHs may guide future techniques in predictive dosimetry.

Project description:Transarterial radioembolization (TARE) is a form of brachytherapy in which intra-arterially injected yttrium-90-loaded microspheres serve as a source for internal radiation purposes. On the average, it produces disease control rates exceeding 80% and it is a consolidated therapy for hepatocellular carcinoma (HCC); however, current data are all based on retrospective series or non-controlled prospective studies since randomized controlled trials comparing it with the other liver-directed therapies for intermediate and locally advanced stage HCC are still underway. The data available show that TARE provides similar or even better survival rates when compared to transarterial chemoembolization (TACE). First-line TARE is best indicated for both intermediate-stage patients (staged according to the barcelona clinic liver cancer staging classification) who have lesions which respond poorly to TACE due to multiple tumors or a large tumor burden, and for locally advanced-stage patients with solitary tumors, and segmental or lobar portal vein tumor thrombosis. In addition, emerging data have suggested the use of TARE in patients who are classified slightly beyond the Milan criteria regarding radical treatment for downstaging purposes. As a second-line treatment, TARE can also be applied in patients progressing to TACE or sorafenib; a large number of phase II/III trials are ongoing with the purpose of evaluating the best association with systemic therapies. Transarterial radioembolization is very well tolerated and has a low rate of complications which are mainly related to unintended non-target tissue irradiation, including the surrounding liver parenchyma. The complications can be additionally reduced by accurate patient selection and a strict pre-treatment evaluation including dosimetry and assessment of the vascular anatomy. Since a correct treatment algorithm for potential TARE candidates is not clear and standardized, this comprehensive review analyzes the best selection criteria for patients who really benefit from TARE and also the new advances of this therapy, which can be a very important weapon against HCC.

Dataset Information

Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial.

Purpose

Materials and methods

Results

Conclusions

Publications

Accuracy and Safety of Scout Dose Resin Yttrium-90 Microspheres for Radioembolization Therapy Treatment Planning: A Prospective Single-Arm Clinical Trial.

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