Recruiting

Surgical Debulking

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT06016855

Conditions

Digestive System Neuroendocrine Tumor G1

Digestive System Neuroendocrine Tumor G2

Metastatic Digestive System Neuroendocrine Neoplasm

Metastatic Malignant Neoplasm in the Liver

Pancreatic Neuroendocrine Tumor G1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumor Debulking

Lutetium Lu 177 Dotatate

Computed Tomography

Magnetic Resonance Imaging

Copper Cu 64 Dotatate

Study Details

Brief summary:

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs

Conditions

Digestive System Neuroendocrine Tumor G1

Digestive System Neuroendocrine Tumor G2

Metastatic Digestive System Neuroendocrine Neoplasm

Metastatic Malignant Neoplasm in the Liver

Pancreatic Neuroendocrine Tumor G1

Study ID

NCT06016855

Start date

May 31, 2024

Status verified date

May, 2026

Completion date

May 28, 2028

Anticipated

Primary completion date

May 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed and dated written informed consent
  • Male or female >= 18 years of age on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =< 20%)
  • Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan performed within 6 months (180 days) prior to surgical debulking on study day 0. The somatostatin receptor avidity of the majority of suspected NET lesion(s) must be >= normal liver uptake
  • Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease
  • White blood cell count (WBC) >= 2000/uL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Platelets >= 75,000/uL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Hemoglobin >= 8.0 g/dL (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Creatinine clearance (CrCl) >= 30 mL/minute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate \[eCCR\] >= 30 mL/min required for eligibility inclusion; or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Total bilirubin =< 3.0 times institutional upper limit of normal (ULN) (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Serum albumin >= 3.0 g/dL unless the prothrombin time is within normal range (resulted =< 90 days prior to surgical debulking on day 0 of participation in this study)
  • Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate
  • A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until 7 months after her final dose of lutetium Lu 177 dotatate
  • A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of lutetium Lu 177 dotatate

Exclusion Criteria:

  • Patient has any tumor > 3 cm deemed to be inoperable
  • Patient has disease which is considered to be completely surgically resectable
  • Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)
  • Prior receipt of peptide receptor radionuclide therapy (PRRT)
  • Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)
  • Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia
  • Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's completion of the study

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (surgical debulking, 177Lu dotatate)

Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.

Interventions

Tumor Debulking

Undergo surgical debulking

Lutetium Lu 177 Dotatate

Given by IV

Computed Tomography

Undergo Computed Tomography

Magnetic Resonance Imaging

Undergo Magnetic Resonance Imaging

Copper Cu 64 Dotatate

Given by IV

Positron Emission Tomography

Undergo Positron Emission Tomography

Primary outcome measure

  • Somatostatin receptor standardized uptake values (SSTR SUV) [ Time Frame: Up to 2 years ]
  • Progression-free survival [ Time Frame: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years ]
  • Overall response rate [ Time Frame: Up to 2 years ]
  • Overall survival [ Time Frame: From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years ]
  • Incidence of adverse events [ Time Frame: Up to 2 years ]
  • Gene mutations [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480cip@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Vanderbilt-Ingram Service for Timely Access

800-811-8480cip@vumc.org

Principal Investigator:

Kamran Idrees, MD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Jun 24, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2026-06-24.