Contrast-enhanced ultrasound to track how PRRT works in gastroenteropancreatic neuroendocrine tumors
Role of Dynamic Contrast-enhanced Ultrasound (D-CEUS) in Assessment of Response to Radioreceptor Therapy (PRRT) in Patients With Pancreatic and Gastrointestinal Tract Neuroendocrine Tumors (GEP-NET)
This tests whether contrast-enhanced ultrasound can show treatment response to peptide receptor radionuclide therapy (PRRT) in adults with unresectable somatostatin-receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT07319416 on ClinicalTrials.gov |
What this trial studies
This interventional imaging study uses dynamic contrast-enhanced ultrasound (DCEUS) and the VueBox platform to monitor tumor perfusion changes in patients receiving peptide receptor radionuclide therapy (PRRT) with lutetium‑177. Eligible adults have histologically confirmed, unresectable well‑differentiated GEP‑NETs (WHO G2–G3) with homogeneous somatostatin receptor positivity on PET‑CT or SPECT and at least one RECIST v1.1 target lesion. Participants will undergo baseline and post‑treatment DCEUS examinations to correlate perfusion metrics with treatment response. The goal is to determine whether DCEUS biomarkers track therapeutic effect and could complement conventional imaging during PRRT.
Who should consider this trial
Good fit: Adults (≥18) with unresectable, well‑differentiated GEP‑NETs (Ki‑67 >2% up to 55%), homogeneous somatostatin receptor positivity on PET/SPECT, at least one RECIST v1.1 target lesion, and ability to give informed consent are ideal candidates.
Not a fit: Patients with somatostatin receptor‑negative tumors, concurrent other malignancies, known hypersensitivity to lutetium‑177 or radionuclides, or those unable to provide informed consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive, radiation‑free way to detect early response to PRRT and help personalize ongoing treatment decisions.
How similar studies have performed: PRRT with lutetium‑177 has proven benefit in NETs, but using DCEUS to monitor PRRT response is relatively novel and has only limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed diagnosis of unresectable, well-differentiated GEP-NET G2 or G3 according to WHO 2019 Classification with a Ki67 index \> 2% up to 55%. * Somatostatin receptor-positive (SSTR+) disease defined by a homogenous SSTRs expression by SSA positive PET-CT or SPECT imaging. * At least one target lesion according to RECIST v1.1. * Participants must have signed and dated an approved written informed consent and must be able to comply with any study specific procedure. Exclusion Criteria: * Known hypersensitivity to Lutetium 177Lu - radionuclides. * Other known malignancies. * Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
Where this trial is running
Rome, Rome
- IRCCS Policlinico Universitario Agostino Gemelli — Rome, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Assunta Zocco, MD, PhD
- Email: mariaassunta.zocco@unicatt.it
- Phone: 0630155057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.