68Ga-DOTA-TATE for Neuroendocrine Tumors

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
CHUS, Sherbrooke, Canada
Neuroendocrine Tumors
68Ga-DOTA-TATE - DiagnosticTest
Eligibility
Any Age
All Sexes
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Study Summary

This study is evaluating whether a new PET scan can be used to detect neuroendocrine tumors.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether 68Ga-DOTA-TATE will improve 1 primary outcome and 2 secondary outcomes in patients with Neuroendocrine Tumors. Measurement will happen over the course of 5 years.

5 years
Generate clinical information on the impact of 68Ga-DOTA-TATE for NET patient management
Instigate the routine standard-of-care use of 68Ga-DOTA-TATE for NET patients
Safety profile of 68Ga-DOTA-TATE

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Neuroendocrine cancer patients
1 of 1
Experimental Treatment

This trial requires 5000 total participants across 1 different treatment group

This trial involves a single treatment. 68Ga-DOTA-TATE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Neuroendocrine cancer patients
DiagnosticTest
All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Who is running the study

Principal Investigator
D. É. E. T.
Dr Éric E Turcotte, MD
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Closest Location

CHUS - Sherbrooke, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor Patients with suspected or proven tumors expressing somatostatin receptors
Informed consent by patient (or parents if patient is less than 18 years of age)

Patient Q&A Section

How many people get neuroendocrine tumors a year in the United States?

"The incidence rate of neuroendocrine tumors in the United States is 0.9 per 1,000,000 persons a year, which is comparable to rates in the United Kingdom and France. Furthermore, the prognosis in the United States is in line with rates in the United Kingdom and France. In our experience, these rates seem to be stable, and their increase appears to be less than that seen for most malignancies in older people in the United States; therefore we consider the incidence values reasonable." - Anonymous Online Contributor

Unverified Answer

What is neuroendocrine tumors?

"These disorders have an incidence between 0.3 and 5.0 per 1,000,000 per year in industrialized countries, but they occur as frequently as other cancers are. Neuroendocrine neoplasms have an unpredictable course, and they are often overlooked and misdiagnosed. The present article gives an overview of the different entities occurring in neuroendocrine glands. The diagnosis will include a careful search for the presence of a neuroendocrine-forming tumor either as the only one or associated with syndromes such as multiple endocrine neoplasia type 1 or 2." - Anonymous Online Contributor

Unverified Answer

What are the signs of neuroendocrine tumors?

"The symptoms related to the presence of a NET in a patient vary according to the type of tumor detected. The most common symptoms are digestive disturbances such as diarrhea or constipation with weight loss, but non-cancerous tumors may present with signs and symptoms of hormonal imbalance. The signs and symptoms must be differentiated with a high degree of accuracy in order to allow the appropriate management and to prevent possible complications." - Anonymous Online Contributor

Unverified Answer

What causes neuroendocrine tumors?

"Neuroendocrine tumors are often of the gastrointestinal or pulmonary type and usually manifest as endocrine gland tumors (EGT). Although not definitive, a history of exposure to radioactive substances, particularly to technetium, in childhood is a risk factor. A single radionuclide study of the entire body can provide additional information and should be considered in patients who develop EGT." - Anonymous Online Contributor

Unverified Answer

Can neuroendocrine tumors be cured?

"Only a small subgroup of patients have the ability to maintain remission after the first-line treatment is terminated. Even in this subgroup of patients, the cumulative 10-year survival rate is only 70%. We suggest that long-term follow-up examinations should be scheduled after treatment termination. However, it must be remembered that the disease's natural course is generally progressive." - Anonymous Online Contributor

Unverified Answer

What are common treatments for neuroendocrine tumors?

"Treatment of NENs (including NETs) depends on their specific tumor type and tumor aggressiveness; for example, therapies may be palliative in nature. Common treatments include surgery (with or without surgery), radiation therapy, tyrosine kinase inhibitors, and chemotherapy. Patient's symptoms and tumor progression should guide therapeutic decisions." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets neuroendocrine tumors?

"Results from a recent clinical trial shows a significant increase in the average age of presentation of NET when compared with the age of presentation for melanoma on the skin. With improved longevity as the life expectancy increases, this study will help provide insight into the expected age of presentation for an individual with NET." - Anonymous Online Contributor

Unverified Answer

What is 68ga-dota-tate?

"(68)Ga-DOTA is a reproducible imaging agent for assessing peptide receptors on neuroendocrine tumors. When this compound can be labeled with (86)Ga, imaging uptake can be used to evaluate radionuclide uptake and retention by receptors (e.g. DTH) to help detect neuroendocrine tumors and determine the extent of their disease." - Anonymous Online Contributor

Unverified Answer

Does neuroendocrine tumors run in families?

"We found that NEN may run in families in an autosomal dominant manner with a variable penetrance in an offspring which is associated with features of both type I alveolar rhabdomyosarcoma and pheochromocytoma." - Anonymous Online Contributor

Unverified Answer

How does 68ga-dota-tate work?

"68Ga-DOTATATE has good imaging characteristics, and is useful in imaging the liver, bones, and kidneys, and is of great value in tumor imaging and the determination of the severity of bone and liver disease. PET with 68Ga-DOTA-TATE is a highly specific imaging technique for detecting and determining the severity of bone and liver disease in patients with NET when performed by an experienced radiochemist, and would be a very useful adjunct examination for patients with NET, especially for the evaluation of liver function." - Anonymous Online Contributor

Unverified Answer

Does 68ga-dota-tate improve quality of life for those with neuroendocrine tumors?

"The use of 68Ga-DOTA-TATE in NET patients demonstrated no improvement in QoL, while there was a slight detriment in patients' ability to perform everyday activities without assistance." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in 68ga-dota-tate for therapeutic use?

"The most recent developments in 68Ga-DTPA-sestamibi included the introduction of this radioactive isotope to clinical trials for the non-invasive localization and diagnosis of SPECT and PET imaging of the somatotropic adenoma of the pituitary gland. 68Ga-DTPA-sestamibi can be used as a radiotracer for diagnostic and therapeutic application of imaging and surgery in neuroendocrine tumors. It holds much hope for the treatment of neuroendocrine tumors under the guidance of integrated and complementary therapeutic approaches to increase therapeutic effect by using both radiotherapy and targeted systemic therapy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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