RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration So .... among other things, intratumoral (IT) injection has not been used in routine clinical practice.
Firstly, the safety of an intratumoral procedure is a prime concern in identifying lesions that are safely accessible and injected without causing tumor spread and hemorrhage. Secondly, specialized handling and patient immobilization is required to utilize a delivery device for the administration of an IT drug. Thirdly, the need for specialized equipment, such as ultrasound and the use of image-guided procedures involving ultrasound/computed tomography guidance, is a particular concern to clinicans whose practices who do not routinely perform the placement of a stereotactically placed catheter into a solid tumor under sterile operating room conditions. And fourthly, no standardized procedure is in place to allow for homogeneous distribution of immunotherapeutic agents without the risk of leakage.