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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Hyperglycaemia

Hypokalaemia

Flushing

Oedema peripheral

Dizziness

Dyspnoea

Vomiting

Gamma-glutamyltransferase increased

Hypertension

Weight decreased

Aspartate aminotransferase increased

Insomnia

Anaemia

Blood alkaline phosphatase increased

Cough

Asthenia

Urinary tract infection

Alanine aminotransferase increased

Dyspepsia

Anxiety

Palpitations

Constipation

Flatulence

Blood creatinine increased

Musculoskeletal pain

Pain in extremity

Headache

Malignant neoplasm progression

Hyponatraemia

Influenza like illness

Pyrexia

Haematuria

Blood bilirubin increased

Syncope

Lymphocyte count decreased

Platelet count decreased

Abdominal pain lower

General physical health deterioration

Abdominal pain upper

Alopecia

Small intestinal obstruction

Muscle spasms

Dysgeusia

Neoplasm progression

White blood cell count decreased

Breast cancer stage I

Thrombotic cerebral infarction

Carcinoid crisis

Non-small cell lung cancer

Hyperuricaemia

Haemorrhage intracranial

Pleural effusion

Arteriospasm coronary

Cardiac failure congestive

Duodenal obstruction

Gastrointestinal obstruction

Ileus

Impaired gastric emptying

Generalised oedema

Limb injury

Muscular weakness

Prostate cancer

Transient global amnesia

Acute kidney injury

Renal impairment

Cholecystitis acute

Anal haemorrhage

Ascites

Dehydration

Basal cell carcinoma

Malignant bowel obstruction

Oesophagitis

100%

80%

60%

40%

20%

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