DCEUS to Assess Treatment Response to PRRT in GEP-NET

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07319416
Status
Recruiting
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Conditions

  • Contrast Enhanced Ultrasound
  • NET
  • Radionucleide Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vuebox — DEVICE
    Software that analyses CEUS clips and derives time-intensity curves and quantitative numerical parameters that reflects contrast kinetic patterns.

Study Details

Neuroendocrine tumors (NETs) are a wide group of neoplasms arising from the diffuse neuroendocrine cell system that features significant molecular and biological heterogeneity. They mainly derive from the enterochromaffin cells of the gastroenteropancreatic tract (GEP-NETs) and their incidence and prevalence are steadily rising, possibly as a consequence of improving diagnostic methods and earlier detection. A major feature of GEP-NETs is their somatostatin receptor (SSTR) immunogenicity, which is relevant both for diagnostic and therapeutic purposes. For patients with unresectable or advanced disease, systemic treatment is the standard of care. In this setting, Somatostatin analogues (SSAs) are the standard first line therapy and, even if response rates are low, disease progression is halted in about two thirds of patient. Recently, targeted radionuclide therapy has claimed significant attention as a valuable treatment option for many solid neoplasms. This approach relies on the administration of a radionuclide linked to a carrier-molecule that selectively interacts with tumor associated antigens, being eventually internalized and releasing β-radiation emission and low-energy γ rays directly from the inside of the cancer cells. Peptide Receptor Radionuclide Therapy (PRRT) is strongly recommended in progressive metastatic/inoperable pretreated NETs that showed homogenous SSTRs expression by SSA positive PET-CT or single photon emission computed tomography (SPECT) imaging. Although PRRT is effective in the majority of cases, approximately 15-30% of patients will eventually progress during treatment. It is still challenging to distinguish potential responders versus non-responder patients. The identification of predictive biomarkers, apart from the required expression of somatostatin receptors, and of non-invasive diagnostic predictive exams, are an unmet need. Despite the promising clinical results, very little is known about the biological changes induced by PRRT on cancer tissue and tumor microenvironment and vascularization. The assessment of treatment' response therefore still relies on CT and PET-CT as markers of tumoral activity. Among imaging modalities, ultrasound could play a key role in this setting. Indeed, contrast-enhanced ultrasound (CEUS) allows a thorough assessment of tumor perfusion through analysis of both contrast media flow pattern and time-intensity curves. This quantitative analysis, called dynamic contrast enhanced ultrasound (DCE-US) is a novel technique that estimates tissue perfusion based on phase-specific enhancement after the injection of microbubble contrast agents. The parameters derived from this analysis could be used for treatment monitoring in oncology, as they are easily comparable through time in each patient. In order to establish the bases for standardization of DCE-US, the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) recently published an update on this topic.

Key Dates

Start date
Dec 11, 2025
Status verified
Dec 2025
Primary completion
Mar 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: GEP-NET
    NET patients enrolled who undergo CEUS in order to assess early treatment response to PRRT

Primary Outcome Measure

Evaluation of tumour vascularization [ Time Frame: - Firs evaluation: at baseline before initiation of PRRT - within 10 days after completion of any pre-planned PRRT therapy (which are planned every 8 weeks) - 6 months after last treatment - 9 months after last treatment ]

Central Contacts

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