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Drug Trials Snapshots: FLUORODOPA F 18

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 FLUORODOPA F 18 Package Insert for complete information.

FLUORODOPA F 18
The Feinstein Institutes for Medical Research
Approval date: October 10, 2019


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

FLUORODOPA F 18 is a drug for the visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS).

PS is a group of movement disorders characterized by slow movements, body stiffness, shakiness at rest and inability to maintain posture. It is associated with the damage/loss of dopaminergic nerves in one part of the brain (called striatum).

How is this drug used?

FLUORODOPA F 18 is injected into a vein (intravenous) in preparation for an imaging test (called Positron Emission Tomography scan or PET scan) to help detect the damaged or lost dopaminergic nerve cells. It is to be used in addition to other tests for diagnosing the PS.

What are the benefits of this drug?

Brain images made with FLUORODOPA F 18 make clinical diagnosis of PS more certain.

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

Efficacy results are summarized below. The primary outcome was the positive and negative percent reader agreement of F-18 FDOPA Injection PET image results with the reference clinical diagnostic standard of PS.

Table 1. Positive and Negative Percent Agreement for F-18 FDOPA Injection PET Imaging

N=56 Patients Positive percent agreement
(95 % CI)
Negative percent agreement
(95 % CI)
Reader 1 73 (55, 87) 91 (72, 99)
Reader 2 49 (31, 67) 91 (72, 99)
Reader 3 58 (39, 75) 83 (61, 94)

FLUORODOPA F 18 Prescribing Information

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

  • Sex: FLUORODOPA F 18 worked similarly in men and women.
  • Race: Data not collected.
  • Age: FLUORODOPA F 18 worked similarly in patients younger and those older than 65 years of age.

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

The tables below summarize efficacy results by sex and age groups. Data on race have not been collected.

Table 2. Subgroup Analysis by Sex (Men)

Final SOR Reader 1 Reader 2 Reader 3
  + - Total + - Total + - Total
PS (+) 15 6 21 11 10 21 12 9 21
Non-PS (-) 1 16 17 1 16 17 3 14 17
Total 16 22 38 12 26 38 15 23 38
PPA (%)
95% CI (Exact)
71
(48, 89)
52
(30, 74)
57
(34, 78)
NPA (%)
95% CI (Exact)
94
(71, 100)
94
(71, 100)
82
(57, 96)
PPV (%)
95% CI (Exact)
94
(70, 100)
92
(62, 100)
80
(52, 96)
NPV (%)
95% CI (Exact)
73
(50, 89)
62
(41, 80)
61
(39, 80)

Table 3. Subgroup Analysis by Sex (Women)

Final SOR Reader 1 Reader 2 Reader 3
  + - Total + - Total + - Total
PS (+) 9 3 12 5 7 12 7 5 12
Non-PS (-) 1 5 6 1 5 6 1 5 6
Total 10 8 18 6 12 18 8 10 18
PPA (%)
95% CI (Exact)
75
(43, 95)
42
(15, 72)
58
(28, 85)
NPA (%)
95% CI (Exact)
83
(36, 100)
83
(36, 100)
83
(36, 100)
PPV (%)
95% CI (Exact)
90
(56, 100)
83
(36, 100)
88
(47, 100)
NPV (%)
95% CI (Exact)
88
(47, 100)
42
(15, 72)
50
(19, 81)

Table 4. Subgroup Analysis by Age (< 65 years)

Final SOR Reader 1 Reader 2 Reader 3
  Positive Negative Total Positive Negative Total Positive Negative Total
PS (+) 10 4 14 7 7 14 9 5 14
Non-PS (-) 0 7 7 0 7 7 0 7 7
Total 10 11 21 7 7 21 9 12 21
PPA (%)
95% CI (Exact)
71
(42, 92)
50
(23, 77)
64
(35, 87)
NPA (%)
95% CI (Exact)
100
(59, 100)
100
(59, 100)
100
(59, 100)
PPV (%)
95% CI (Exact)
100
(69, 100)
100
(59, 100)
100
(66, 100)
NPV (%)
95% CI (Exact)
64
(31, 89)
50
(23, 77)
58
(28, 85)

Table 5. Subgroup Analysis by Age (>= 65 years)

Final SOR Reader 1 Reader 2 Reader 3
  Positive Negative Total Positive Negative Total Positive Negative Total
PS (+) 14 5 19 9 10 19 10 9 19
Non-PS (-) 2 14 16 2 14 16 4 12 16
Total 16 19 35 11 24 35 14 21 35
PPA (%)
95% CI (Exact)
74
(49, 92)
47
(24, 71)
53
(29, 76)
NPA (%)
95% CI (Exact)
88
(62, 98)
88
(62, 98)
75
(48, 93)
PPV (%)
95% CI (Exact)
88
(62, 98)
82
(48, 98)
71
(42, 92 )
NPV (%)
95% CI (Exact)
74
(49, 92)
58
(37, 76)
57
(34, 78)

SOR: standard of reference; PPA: positive percent agreement, NPA: negative percent agreement; PPV: positive predictive value; NPV: negative predictive value; CI: confidence interval

Courtesy of FDA Statistical Review Team

What are the possible side effects?

FLUORODOPA F 18 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)?

No adverse reactions have been reported for Fluorodopa F 18 Injection in the clinical trial.

FLUORODOPA F 18 Prescribing Information

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

No side effects were reported in clinical trial; therefore, subgroup differences could not be evaluated.

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

Not analyzed because no adverse reactions were reported in clinical trials.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved FLUORODOPA F 18 based on evidence from one clinical trial of 56 patients with suspected PS. The trial was conducted at one clinical site in the United States.

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

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 38 men (68%) and 18 women (32%) participated in the clinical trial.

Clinical Trial Data

Baseline Demographics by Race-data not collected

Figure 2 summarizes the percentage of patients by age group in the clinical trial.

Figure 2. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total, 21 patients were less than 65 years old (37%) and 35 patients were 65 years and older (63%).)

Clinical Trial Data

Who participated in the trials?

The tables below summarize baseline demographic information for the trial population.

Table 6. Demographic Characteristics

Demographic Parameter N=56
n (%)
Sex
Men 38 (67.9%)
Women 18 (32.1%)
Race-not collected
Age (years)
Mean (SD) 66.0 (14.10)
Min. Max 22, 100
Age Group (years)
< 65 21 (37.5)
> 65 35 (62.5)
Ethnicity-not collected
Region
United States 56 (100%)

Clinical Trial Data

How were the trials designed?

The benefit and side effect of FLUORODOPA F 18 were evaluated in one clinical trial of 56 patients with suspected PS. All patients received a single intravenous dose of FLUORODOPA F 18 before getting PET scan. PET scan Images were read by three readers who had no knowledge about patient’s condition.

The benefit was assessed by comparing the accuracy of FLUORODOPA F 18 images to detect nerve damage/loss with clinical diagnosis of PS 6-9 months after imaging.

How were the trials designed?

The safety and efficacy of FLUORODOPA F 18 were established in a prospective single-arm study conducted at a single center that enrolled 68 adult patients with possible Parkinsonian syndrome (PS). Patients received a single dose of FLUORODOPA F 18. The imaging results were compared to a reference clinical diagnostic standard of Parkinsonian syndrome or non-Parkinsonian syndrome (non-PS) established at 6 to 9 months after the F-18 FDOPA PET scan by a movement disorder specialist blinded to FDOPA F-18 PET results.

The primary outcome was the positive and negative percent agreement of FLUORODOPA F-18 Injection PET image results with the reference clinical diagnostic standard.

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.

PRESCRIBING INFORMATION

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