Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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).

More Contrast Enhanced Ultrasound trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionsradiation
Locations1 site (Rome, Rome)
StatusRecruiting
StartedDecember 11, 2025
Main results expectedMarch 1, 2027
Study endsOctober 1, 2027
Registry record updatedJanuary 6, 2026
Trial IDNCT07319416 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.