Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04609592
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Lutathera — DRUG
    4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T
  • Gallium 68 Dotatate — DRUG
    Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
  • Computed Tomography (CT) — PROCEDURE
    Medical Imaging
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Medical Imaging
  • PET/CT — PROCEDURE
    Medical Imaging

Study Details

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

Key Dates

Start date
Mar 17, 2021
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lutathera
    2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT

Primary Outcome Measure

Measure Complication free Surgery [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Cancer Institute Palo AltoStanfordCalifornia95304
Brendan C Visser, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Stanford Cancer Institute Palo Alto· Stanford, CA

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