Lutetium-177 Radiopharmeceutical Therapy Extravasation Lessons Learned

Berry, Kendall; Kendrick, Jessica

doi:10.1097/hp.0000000000001558

Cited by 7 publications

(10 citation statements)

References 4 publications

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“…For three common radiopharmaceutical isotopes, we determined appropriate values for volume and initial radioactivity based on typical clinical administrations with assumed extravasations of 25% and 50%. Rates of biological clearance were based on values found in the literature (Osborne et al 2021; Berry and Kendrick 2022). Table 1 shows details of each extravasation scenario we investigated.…”

Section: Methodsmentioning

confidence: 99%

Dose Estimation for Extravasation of 177Lu, 99mTc, and 18F

Tsorxe

Hayes

2023

Health Physics

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Extravasation is the situation in which a nuclear medicine injection deposits some fraction of its radioactivity into the soft tissue rather than the bloodstream and may result in a large local radiation dose to tissue. An understanding of localized radiation dose from such unexpected events can be an important aspect of clinical radiation protection. The aim of this study was to estimate and assess absorbed radiation dose to localized soft tissue for hypothetical scenarios of radiopharmaceutical extravasation. Specifically, the goal was to understand whether a radiopharmaceutical extravasation could exceed the US Nuclear Regulatory Commission’s medical event reporting limit of 0.5 Sv dose equivalent to tissue or levels at which tissue damage would be anticipated (1.0 Sv dose equivalent). We used the GATE Monte Carlo simulation software to calculate self-dose to spherical volumes containing uniformly distributed amounts of common radiopharmaceutical isotopes. Simulated volumes, radioactivity levels, and effective half-lives represented real-world nuclear medicine procedures. Chosen scenarios consisted of 50 mCi and 100 mCi 177Lu within 20 cm3 and 40 cm3 tissue volumes and a 60 min biological clearance half-time (59.6 min effective half-life), 6 mCi and 12 mCi 99mTc within 1 cm3 and 5 cm3 tissue volumes and a 120 min biological clearance half-time (90 min effective half-life), and 3 mCi and 6 mCi 18F within 1 cm3 and 5 cm3 tissue volumes with a 30 min biological clearance half-time (23.6 min effective half-life). We calculated absorbed doses to be between 5.5 Gy and 23.5 Gy for 177Lu, between 0.9 Gy and 12.4 Gy for 99mTc, and between 1.5 Gy and 16.2 Gy for 18F. Radiopharmaceutical extravasations can result in tissue doses that surpass both medical event reporting limits and levels at which deterministic effects are expected. Radiation safety programs should include identification, mitigation, dosimetry, and documentation of significant extravasation events.

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Section: Methodsmentioning

confidence: 99%

Dose Estimation for Extravasation of 177Lu, 99mTc, and 18F

Tsorxe

Hayes

2023

Health Physics

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“…An example of additional actions on how to evaluate the dose to the injection site has been published elsewhere for Lu‐177 DOTATATE. 27 …”

Section: Generate the Written Procedures And Accompanying Formsmentioning

confidence: 99%

“…An example of additional actions on how to evaluate the dose to the injection site has been published elsewhere for Lu-177 DOTATATE. 27 For Task (4c.iii. ), post-therapy procedures include determination of the administered activity, patient monitoring, patient release and radiation safety instruction, handling of certain situations after release, contamination checks, and area release.…”

Section: Generate the Written Procedures And Accompanying Formsmentioning

confidence: 99%

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Zoberi

Garcia-Ramirez

Luechtefeld

et al. 2023

J Applied Clin Med Phys

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Prostate‐specific membrane antigen (PSMA) is a cell surface protein highly expressed in nearly all prostate cancers, with restricted expression in some normal tissues. The differential expression of PSMA from tumor to non‐tumor tissue has resulted in the investigation of numerous targeting strategies for therapy of patients with metastatic prostate cancer. In March of 2022, the FDA granted approval for the use of lutetium‐177 PSMA‐617 (Lu‐177‐PSMA‐617) for patients with PSMA‐positive metastatic castration‐resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane‐based chemotherapy. Therefore, the use of Lu‐177‐PSMA‐617 is expected to increase and become more widespread. Herein, we describe logistical, technical, and radiation safety considerations for implementing a radiopharmaceutical therapy program, with particular focus on the development of operating procedures for therapeutic administrations. Major steps for a center in the U.S. to implement a new radiopharmaceutical therapy (RPT) program are listed below, and then demonstrated in greater detail via examples for Lu‐177‐PSMA‐617 therapy.

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“…We understand that not all procedures go as planned. But when they don't, we expect and need to be told, since these procedures directly or indirectly affect our care (1)(2)(3)(4)(5)(6)(7)(8). If we need additional therapy delivered or if we need to repeat an imaging procedure because of an extravasation, we expect this information to be shared with us and that actions be taken to prevent a repeat extravasation.…”

Section: Patient Carementioning

confidence: 99%

Transparency – a patient-centric view on radiopharmaceutical extravasations

Kohl¹

2023

Front. Nucl. Med.

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Most radiopharmaceuticals are intravenously administered during nuclear medicine imaging or therapy procedures. When a nuclear medicine clinician delivers some or all of a radioactive drug into a patient's healthy tissue rather than the vein as intended, a patient experiences an extravasation. Radiopharmaceutical extravasations provide zero patient benefit and considerable potential downsides, depending on the severity of the extravasations. What nuclear medicine patients want and need regarding the administration of radiopharmaceuticals is transparency. And yet in the year 2023, little transparency exists regarding these extravasations. From the patient perspective, transparency regarding extravasations is essential to improving care, ensuring radiation protection, reducing health inequities, and untangling the deeply disturbing and irregular relationship between the nuclear medicine community and their regulating body, The U.S. Nuclear Regulatory Commission. Transparency is also critical to help address many other questions regarding radiopharmaceutical extravasations.

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Lutetium-177 Radiopharmeceutical Therapy Extravasation Lessons Learned

Abstract: Medical radiation safety officers (RSOs) need to understand the risk of extravasations associated with radiopharmaceutical infusion therapies, and this case study can help RSOs be prepared to respond to an extravasation at their facility.

Cited by 7 publications

References 4 publications

Dose Estimation for Extravasation of 177Lu, 99mTc, and 18F

Dose Estimation for Extravasation of 177Lu, 99mTc, and 18F

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Transparency – a patient-centric view on radiopharmaceutical extravasations

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