Back to search results

Surgical Debulking and Lutetium Lu 177 Dotatate for Neuroendocrine Tumors

This study is looking at how well a combination of treatments works for people with certain types of digestive system or pancreatic neuroendocrine tumors (GEP-NETs) that have spread to the liver. You would first have surgery to remove as much of the tumor as possible (surgical debulking). Then, you would receive Lutetium Lu 177 dotatate, a radioactive drug that targets and kills tumor cells. Researchers want to see how many people respond to this treatment, how safe it is, and how long people live without their cancer growing. To join, you must be at least 18 years old, have a specific type of GEP-NET (grade 1 or 2) that is somatostatin receptor positive, and be able to perform daily activities with little to no difficulty. The study aims to enroll 6 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a single-arm study, meaning all participants receive the same treatment combination.
What's involved
You would undergo surgical debulking, then receive Lutetium Lu 177 dotatate intravenously every 56 days for up to 4 cycles. You will also have CT scans, MRI scans, and Copper Cu 64 Dotatate PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed up at 30-37 days after the last dose, and then every 3 months for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06016855

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Recruiting
PHASE4Ages 18+InterventionalTreatment
Vanderbilt-Ingram Cancer Center
~6 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Tumor DebulkingLutetium Lu 177 DotatateComputed TomographyMagnetic Resonance ImagingCopper Cu 64 DotatatePositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Somatostatin receptor standardized uptake values (SSTR SUV)
Measured over Up to 2 years
+5 more outcomes measured

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
Pancreatic Neuroendocrine Tumor G2

Explore related trials

Digestive System Neuroendocrine TumorPancreatic Neuroendocrine TumorMKI67 GeneSomatostatin Receptor

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Kamran Idrees, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

Vanderbilt-Ingram Services for Timely Access
[email protected]
800-811-8480
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Somatostatin receptor standardized uptake values (SSTR SUV)Up to 2 years

    SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.

  • Progression-free survivalFrom the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years

    Will be estimated by the Kaplan-Meier method.

  • Overall response rateUp to 2 years

    Will be estimated by measuring the number of patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria on restaging computed tomography or magnetic resonance imaging scans =\< 6 months from PRRT completion, from the total number of patients who received the study treatment and possessed measurable disease post-surgical debulking. The number of patients who possessed measurable disease which did not meet RECIST 1.1 eligibility criteria post-surgical debulking will also be recorded.

  • Overall survivalFrom the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years

    Will be estimated by the Kaplan-Meier method.

  • Incidence of adverse eventsUp to 2 years

    Toxicity will be estimated by documenting the grade 3/4 adverse events, according to Common Terminology Criteria for Adverse Events version 5.0, experienced by study patients.

  • Gene mutationsUp to 2 years

    Mutations in genes associated with radioresistance (defined from other malignancies) and other mutations in large resected neuroendocrine tumors will be recorded. Mutations will be described descriptively.