Drugs

Drug Trials Snapshot: Netspot

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection) Prescribing Information for complete information.

NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection)
(net spot)    
Advanced Accelerator Applications
Approval date: June 1, 2016


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

NETSPOT is a drug for detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs).

NETs are rare tumors that develop in certain hormone-producing cells of the body’s neuro-endocrine system.

How is this drug used?

NETSPOT is injected into a vein (intravenous) in preparation for an imaging test (called positron emission tomography scan or PET scan) to help detect the tumor.

What are the benefits of this drug?

NETSPOT shows the sites of neuro-endocrine tumors.

What are the benefits of this drug (results of trials used to assess efficacy)?

The efficacy of NETSPOT was established in three open-label, single center trials (Study A-C).

In Trial A, 97 adult patients with known or suspected neuroendocrine tumors (NETs) were evaluated with gallium Ga 68 dotatate. The images were read by two independent readers blinded to clinical information. The reads were compared to CT and/or MR images and to indium In 111 pentetreotide images obtained with Single Photon Emission Computed Tomography (SPECT) within previous 3 years. Among 78 patients in whom CT and/or MR images and In 111 pentetreotide images were available, gallium Ga 68 dotatate PET was in agreement with the CT and/or MR images in 74 patients. Out of 50 patients with NETs localized by CT and/or MR imaging, gallium Ga 68 dotatate was positive in 48 patients including 13 patients in whom In 111 pentetreotide was negative. gallium Ga 68 dotatate was negative in 26 out of 28 patients in whom CT and/or MR imaging was negative.

In Trial B (published study), 36 out of 104 patients with suspected neuroendocrine tumors were found by CT and/or MRI and SPECT to have pathology confirmed NET. In 29 out of 36 of these patients, gallium Ga 68 dotatate PET correctly identified the NET site. It was falsely negative in 7 out of 36 of these patients. In 61 out of 68 patients, where CT and/or MRI and SPECT did not identify a NET, gallium Ga 68 dotatate also did not identify a NET. In 7 out of 68 patients it was falsely positive.

In Trial C (published study), 63 patients with known neuroendocrine tumors were evaluated for tumor recurrence by combined CT and/or MRI and SPECT and compared to scans obtained from gallium Ga 68 dotatate PET. In 23 out of 29 patients with tumor recurrence, gallium Ga 68 dotatate PET correctly located the tumor. In 29 out of 34 patients where there was no tumor recurrence, Ga 68 dotatate PET also showed no tumor recurrence.

Were there any differences in how well the drug worked in clinical trials among sex, race and age groups?

No subgroup analyses were done because of limited data for sex, race or age of the trial participants.

Were there any differences in how well the drug worked in clinical trials among sex, race and age groups?

No subgroup analyses were done for sex, race or age because of limited demographic data.

What are the possible side effects?

There were few adverse reactions; none of which were serious.

NETSPOT is a radioactive drug which may increase the risk of lifetime radiation exposure.

What are the possible side effects (results of trials used to assess safety)?

Since adverse reactions were rare, subgroup analyses for sex, race or age were not done.

Were there any differences in side effects among sex, race and age?

Since adverse reactions were rare, subgroup analyses for sex, race or age were not done.

Were there any differences in side effects of the clinical trials among sex, race and age groups?

No subgroup analysis was performed by sex, race and age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved NETSPOT based upon three trials. The trials involved 265 adults who had known or suspected neuro-endocrine tumors.

The trials were conducted in the USA and Germany.

The figure below summarizes how many men and women were in the clinical trials.
 

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials of the drug NETSPOT. In total, 128 men (48%) and 137 women (52%) participated in the clinical trials.

Source: NETSPOT Prescribing Information

Baseline Demographics by Race

Information on race was not available.

Baseline Demographics by Age

The patient’s ages were from 20 to 83 years but individual patient’s data were not reported.

Who participated in the trials?

The table below summarizes known demographic data from all there trials combined.

Table 1. Baseline Demographics

 Demographic Parameter Total (N=265)
  Sex
 Men 128 (48%)
 Women 137 (52%)
  Age
 Mean years 56.6
 Min, max (years) 20, 83
  Race was not reported 
  Region 
 United States 97
 Germany 168
Source: NETSPOT Prescribing Information

How were the trials designed?

Trial A compared gallium Ga 68 dotatate images to other images taken by different techniques to detect the site of a tumor.

Trial B compared tumor site localization using gallium Ga 68 dotatate images to either tumor biopsy or clinical confirmation.

Trial C compared localization of tumor site recurrence using gallium Ga 68 dotatate images to either tumor biopsy or clinical confirmation.

How were the trials designed?

There were three single-center, open-label trials. Trial A was a study conducted at Vanderbilt University Medical Center and Trials B and C were studies published in medical journals.

In Trial A, patients with known or suspected neuroendocrine tumors (NETs) were evaluated with Ga 68 dotatate positron emission tomography (PET) scan. Two independent readers blinded to clinical information compared the Ga 68 dotatate PET scans to previously obtained CT and/or MRI images and 111 (indium) pentetreotide images obtained with a Single Photon Emission Computed Tomography (SPECT) scan in the prior 3 years.

In Trial B (published study), patients with suspected NETs were evaluated with Ga 68 dotatate PET scan. Two readers interpreted Ga 68 dotatate images to visualize the location of tumor sites and compared them to either histopathology or clinical follow up of up to 5 month duration.

In Trial C (published study), patients with known NETs were evaluated for tumor recurrence by Ga 68 dotatate PET. Two readers blinded to clinical information independently interpreted the Ga 68 dotatate images to visualize the location of tumor sites and compared them to either histopathology or clinical follow up.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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