Contrast-enhanced ultrasound to track how PRRT works in gastroenteropancreatic neuroendocrine tumors
Official title: 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)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07319416 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | December 11, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT07319416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
International effort to set liver CEUS image-quality standards and a rating tool
A group of experts is testing a standardized set of quality criteria and a rating tool to judge liver CEUS images.
-
Contrast ultrasound imaging of uterine spiral arteries after delivery
We will try using contrast-enhanced ultrasound after delivery to visualize small uterine spiral arteries and measure uterine artery blood flow in people with a single pregnancy at term who deliver at Máxima Medical Center.
-
Using contrast-enhanced ultrasound to predict lymph node spread in small papillary thyroid cancer
This will test whether contrast-enhanced ultrasound can predict lymph node spread before surgery in people with small (T1N0M0) papillary thyroid cancer.
-
Microwave ablation for papillary thyroid microcarcinoma monitored with contrast-enhanced ultrasound and genetic testing
This project will try microwave ablation guided by contrast-enhanced ultrasound and an 88-gene panel in adults with low-risk papillary thyroid microcarcinoma to see if it controls the tumor while preserving thyroid function.
-
AI-guided ultrasound and MRI staging to guide bladder cancer treatment
This project will test whether a deep-learning system using ultrasound, MRI, and pathology can more accurately stage bladder cancer and predict who will benefit from additional chemotherapy for patients with suspected bladder tumors.
-
Using ultrasound to improve diagnosis of bladder cancer staging
This study is testing if using a special ultrasound technique can help doctors better determine the stage of bladder cancer in patients who haven't had treatment yet.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.