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Radiopharmaceutical

PRRT for Neuroendocrine Tumors

Phase 1
Recruiting
Led By Brendan C Visser, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only
Must not have
Known bone or peritoneal metastases
Prior 177Lu Dotatate treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial investigates the safety & effectiveness of using a radioactive product before & after surgery to treat GEP-NETs, with the goal of increasing overall survival.

Who is the study for?
This trial is for adults with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have somatostatin receptors and are WHO Grade 1 or 2. Candidates must be fit for surgery aimed at removing most of the tumor, have not had certain treatments recently, and their major organs must function well.Check my eligibility
What is being tested?
The study tests Peptide Receptor Radionuclide Therapy (PRRT) using Lutathera before and after surgical removal of tumors in patients with SSTR-positive GEP-NETs. It aims to see if this approach improves survival by combining imaging techniques like PET/CT, CT scans, and MRI.See study design
What are the potential side effects?
Possible side effects include reactions to radioactive materials such as nausea, vomiting, fatigue; blood cell count changes leading to increased infection risk; kidney damage; liver toxicity; allergic reactions to contrast agents used in imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scans show my cancer has somatostatin receptors.
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My cancer has spread to my liver or lymph nodes only.
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I am 18 years old or older.
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I have been on a stable dose of octreotide LAR for at least 12 weeks.
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I can carry out all my self-care but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my bones or abdomen.
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I have previously received 177Lu Dotatate treatment.
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I have cancer that has spread to my brain.
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I haven't had surgery, ablation, or certain radiation treatments affecting a lot of my bone marrow recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transfusion-Free Surgery
Secondary outcome measures
Overall Survival (OS)
Recurrence free Survival (RFS)
Response Rate (RR)

Side effects data

From 2021 Phase 3 trial • 231 Patients • NCT01578239
27%
Fatigue
19%
Abdominal pain
18%
Diarrhoea
13%
Abdominal distension
12%
Nausea
11%
Decreased appetite
10%
Arthralgia
10%
Back pain
9%
Hyperglycaemia
9%
Hypokalaemia
9%
Flushing
9%
Oedema peripheral
9%
Dizziness
8%
Dyspnoea
8%
Vomiting
8%
Gamma-glutamyltransferase increased
7%
Hypertension
7%
Insomnia
7%
Aspartate aminotransferase increased
7%
Weight decreased
7%
Anaemia
7%
Blood alkaline phosphatase increased
7%
Cough
7%
Asthenia
6%
Urinary tract infection
6%
Alanine aminotransferase increased
6%
Dyspepsia
5%
Anxiety
5%
Palpitations
5%
Constipation
5%
Flatulence
5%
Blood creatinine increased
5%
Musculoskeletal pain
5%
Pain in extremity
5%
Headache
4%
Hyponatraemia
4%
Malignant neoplasm progression
4%
Influenza like illness
3%
Pyrexia
3%
Haematuria
3%
Blood bilirubin increased
2%
Syncope
2%
Platelet count decreased
2%
Lymphocyte count decreased
2%
Abdominal pain lower
2%
General physical health deterioration
2%
Abdominal pain upper
2%
Alopecia
2%
Small intestinal obstruction
2%
Muscle spasms
2%
Dysgeusia
1%
White blood cell count decreased
1%
Hyperuricaemia
1%
Neoplasm progression
1%
Thrombotic cerebral infarction
1%
Breast cancer stage I
1%
Pleural effusion
1%
Carcinoid crisis
1%
Non-small cell lung cancer
1%
Haemorrhage intracranial
1%
Arteriospasm coronary
1%
Cardiac failure congestive
1%
Duodenal obstruction
1%
Gastrointestinal obstruction
1%
Ileus
1%
Impaired gastric emptying
1%
Generalised oedema
1%
Limb injury
1%
Muscular weakness
1%
Prostate cancer
1%
Transient global amnesia
1%
Acute kidney injury
1%
Renal impairment
1%
Cholecystitis acute
1%
Anal haemorrhage
1%
Ascites
1%
Dehydration
1%
Basal cell carcinoma
1%
Malignant bowel obstruction
1%
Oesophagitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide LAR
177Lu-DOTA0-Tyr3-Octreotate

Trial Design

1Treatment groups
Experimental Treatment
Group I: LutatheraExperimental Treatment5 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography (CT)
2012
N/A
~100
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
PET/CT
2022
Completed Phase 3
~1270

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peptide Receptor Radionuclide Therapy (PRRT) with 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) targets somatostatin receptors on neuroendocrine tumor cells by binding a radioactive compound to these receptors. This allows for direct delivery of radiation to the tumor cells, causing DNA damage and cell death while sparing surrounding healthy tissue. This targeted approach is significant for NET patients as it offers a treatment option that can effectively control tumor growth and improve quality of life with relatively few severe side effects. Other common treatments include somatostatin analogs, which inhibit hormone secretion and tumor growth, and everolimus, which inhibits the mTOR pathway to reduce cell proliferation. Each of these treatments leverages specific mechanisms to manage NETs, providing tailored therapeutic options based on tumor characteristics and patient needs.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,929 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
25 Patients Enrolled for Neuroendocrine Tumors
Novartis PharmaceuticalsIndustry Sponsor
2,874 Previous Clinical Trials
4,199,981 Total Patients Enrolled
29 Trials studying Neuroendocrine Tumors
2,750 Patients Enrolled for Neuroendocrine Tumors
Brendan C Visser, MDPrincipal InvestigatorStanford Universiy

Media Library

Lutathera (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04609592 — Phase 1
Neuroendocrine Tumors Research Study Groups: Lutathera
Neuroendocrine Tumors Clinical Trial 2023: Lutathera Highlights & Side Effects. Trial Name: NCT04609592 — Phase 1
Lutathera (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609592 — Phase 1
~2 spots leftby Jul 2025