Alpha Tau has treated the first patient in IMPACT, a U.S. multi-center pilot evaluating intratumoral Alpha DaRT in combination with standard chemotherapy for newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma. The single-arm study plans up to 30 patients across the U.S., Canada, and Israel, with primary endpoints focused on implantation feasibility and safety/tolerability (Grade 3+ device-related adverse events). Secondary readouts include local response (RECIST and/or volumetric), time to local progression, progression-free and overall survival, patient-reported pain outcomes, and, in the locally advanced cohort, conversion to surgical resection. Patients continue mFOLFIRINOX, and sources are implanted via endoscopic ultrasound guidance, with follow-up through six months.
The core development involves the operational initiation of a complex, procedure-centric oncology device trial in a notoriously challenging tumor type. Eligibility is restricted to inoperable, non-irradiated patients who are either chemotherapy-naïve or early in first-line treatment; prior surgery or radiation excludes enrollment. Alpha DaRT uses radium-224–impregnated sources designed to emit short-range alpha particles intratumorally, aiming for concentrated local cell kill while limiting exposure to adjacent critical structures in the pancreas. The first procedure was completed at a Houston site, signaling that the workflow—EUS-guided placement during ongoing systemic therapy—can be executed in a community-facing setting with multidisciplinary coordination.
Strategically, this is a calculated expansion from surface-accessible tumors into deep visceral disease, positioning Alpha DaRT as a local-control adjunct in a setting where external-beam radiotherapy and ablative techniques offer inconsistent downstaging and symptom relief. The pilot is designed to de-risk two key questions that will govern any registrational path: can centers reliably perform the implantation without prohibitive complications, and does the local control signal justify a randomized study against chemotherapy alone or chemotherapy plus standard radiation? It also tests a device-first regulatory posture in an indication dominated by drug-centric endpoints, with conversion-to-resection and pain control included to broaden clinical utility beyond response rates.
For sites, the implications are non-trivial. Activation requires endoscopic ultrasound capability, radiation oncology and physics support, and radioactive materials licensing with tight chain-of-custody and time-of-use controls for short half-life sources. Scheduling must synchronize sedation suites, radiation safety, and chemotherapy cycles, and AE attribution will be complicated by overlapping toxicity from mFOLFIRINOX. Imaging-based response and local progression endpoints will likely necessitate centralized reads and consistent volumetric techniques. CROs and vendors with expertise in interventional oncology monitoring, radiation compliance, and device-procedure training will be essential to maintaining tight protocol adherence and minimizing variability across geographies.
Suppose feasibility and safety are demonstrated across multiple centers. In that case, the next logical step is a controlled trial powered for local control and conversion to resection in the locally advanced subset, with a parallel assessment of quality-of-life and pain metrics that could resonate with guideline bodies. Key near-term signals to watch are implantation success rate, procedure-related pancreatitis or bleeding, Grade 3+ device-related events, and any early evidence of durable local control at three and six months. The open questions are whether the FDA will require survival-based endpoints for a pancreatic claim, how Alpha Tau will scale isotope logistics and site training beyond select tertiary centers, and whether the procedure can be standardized enough to support broad adoption. Enrollment velocity across the multi-country network will be the first indication of whether this model can transition beyond pilot feasibility into a platform for larger trials.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
