AzTrials
AzTrials

Neuroendocrine TumorsEarly Phase 1NCT04544098

Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver

A Early Phase 1 study testing 177Lu-DOTATATE in people with Neuroendocrine Tumors and Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu-DOTATATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
2 Sep 2020to Sep 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects affected by histologically proven, somatostatin-receptor positive, progressive, nonresectable, liver-dominant metastatic GEP, bronchial or unknown primary tumors, G1, G2 and G3, according to the new WHO classification of 2017.
  • Ability to understand and willingness to sign a written informed consent document
  • Aged 18 years or older
  • Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization
  • Measurable disease as defined by RECIST 1.1 with at least one dimension ≥ 1.0 cm
  • GEP or unknown primary NET of grade 1, 2 and 3 according to WHO 2017, typical or atypical lung carcinoid according to the Travis classification of 2004
Show all 16Show fewer
  • Progression of disease defined by one of the following occurring within 6 months of study entry:
  • At least a 20% increase in radiologically or clinically measurable disease;
  • Appearance of any new lesion;
  • Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden);
  • Overexpression of somatostatin receptors of the target lesions at 68Ga-DOTATATE PET/CT with SUV of lesions greater than normal liver at least in 1 metastasis.
  • ECOG performance status 0 or 1 (Karnofsky ≥ 70%).
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed >6 weeks prior to study entry. For such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry.
  • Previous oral chemotherapy, biotherapy (such as Interferons or Everolimus) and/or investigational agents are allowed if completed >4 weeks prior to study entry For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
  • Patients must not be candidate for potentially curative surgery. Prior surgery is allowed no less than 6 weeks prior to study entry. Note: Patients who have disease that is amendable to resection but who are not a surgical candidate for other medical reasons would be permitted.

Who cannot join

  • Women who are pregnant or breastfeeding
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE as assessed from medical records.
  • Life expectancy < 6 months as assessed by the treating physician.
  • Over 80% liver involvement by tumor per the judgement of the radiologist
  • Poorly differentiated neuroendocrine neoplasms (Neuroendocrine Carcinoma), small and large cell type; Mixed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
  • Presence of somatostatin receptor negative lesions.
Show all 36Show fewer
  • Prior treatment with other radiolabeled somatostatin analogs.
  • Prior systemic chemotherapy, except oral chemotherapy with capecitabine + temozolomide
  • Contraindication to angiography/embolization including:
  • Patients cannot receive contrast
  • Severe allergic reaction to contrast despite premedication. Patients in who IV contrast is contraindicated are recommended to have MRI abdomen and noncontrast chest CT scan.
  • Poor renal function not on dialysis
  • Other, based on judgment of the investigator
  • Main portal vein tumor thrombus.
  • Deteriorated renal function:
  • Serum creatinine >1.7 mg/dL OR
  • EGFR <30 ml/min
  • Deteriorated bone marrow function:
  • Hb <8.0 g/dL;
  • WBC <3000/mm3;
  • ANC<1500/mm3;
  • Platelets <75.000/mm3
  • Deteriorated liver function:
  • INR > 2.0 for patients that are not on Coumadin or Xarelto
  • PTT > 2x ULN
  • Total bilirubin >3 mg/dl
  • Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
  • Clinically relevant toxicities from prior therapies that have not resolved to grade 1 or grade 0
  • Previous liver radioembolization with 90Y-microspheres.
  • Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized.
  • Uncontrolled diabetes mellitus
  • Inability to interrupt short-acting Octreotide for 24 h before and 24 h after the administration of 177Lu-DOTATATE; inability to have an interval between Octreotide LAR and 177Lu-DOTATATE of ≥4 weeks
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Prior external beam radiation therapy involving >25% of the bone marrow.
  • Unmanageable urinary incontinence rendering the administration of 177Lu-DOTATATE unsafe
  • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Pilot Study Investigating Intrahepatic Arterial And Intravenous Infusion Of The Radiolabeled Somatostatin Agonist 177Lu-DOTATATE In Patients With Liver-Dominant Metastatic Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Well Differentiated Neuroendocrine Tumors

This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). The researchers will also determine whether Lutathera is effective against participants' cancer.

Being tested
177Lu-DOTATATE
Keywords
177Lu-DOTATATE, Pan-NETs, Intrahepatic Arterial, Intravenous Infusion, Gastroenteropancreatic (GEP),, Bronchial or Unknown Primary Well Differentiated Neuroendocrine Tumors
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-DOTATATEDrug

    The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration. The activity per cycle will be fixed for each patient: patients will receive two intra-arterial cycles of 7.4 GBq, unless toxicity occurs requiring dose modifications.

Study groups in NCT04544098
Study groupRoleWhat they receive
PRRT with 177Lu-DOTATATEExperimentalPatients will undergo a routine 68Ga-DOTATATE PET/CT. Patients with sufficient tumor uptake will be offered therapy with 177Lu-DOTATATE. The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration.
Receives: Drug: 177Lu-DOTATATE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients who successfully complete 2 IA injections

    Feasibility will be defined as at least 7 or more patients out of 10 patients who successfully complete 2 IA injections.

    Measured: 2 years

  2. Objective response

    classified according to RECIST 1.1 criteria

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start2 Sep 2020
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an early-phase trial in which a total of 10 patients with progressive, inoperable, liver-dominant, metastatic GEP, bronchial or unknown primary NETs will be enrolled in this combined intraarterial/intravenous therapeutic approach with 177Lu-DOTATATE.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544098
Sponsor's protocol ID
20-232
Status last verified
May 2026
First submitted
3 Sep 2020
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 177Lu-DOTATATE in people with Neuroendocrine Tumors and Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients who successfully complete 2 IA injections (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04544098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in