Post-amphetamine [C-11]NPA PET Scan for Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
University of PIttsburgh, Pittsburgh, PA
Disease+1 More
Post-amphetamine [C-11]NPA PET Scan - Radiation
Eligibility
18 - 65
All Sexes
Eligible conditions
Disease

Study Summary

This study is evaluating whether amphetamine-induced dopamine release in the striatum is correlated with [11C]NOP-1A VT in the midbrain.

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Eligible Conditions

  • Disease
  • Cocaine Use Disorders

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Post-amphetamine [C-11]NPA PET Scan will improve 1 primary outcome in patients with Disease. Measurement will happen over the course of Baseline, and 2.5 to 3 hours post-amphetamine.

Hour 3
DELTA binding potential relative to non displaceable uptake (BPND)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
PET

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Post-amphetamine [C-11]NPA PET Scan 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 < 1 and are in the first stage of evaluation with people.

PET[C-11]NPA PET Scan
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextroamphetamine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, and 2.5 to 3 hours post-amphetamine
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, and 2.5 to 3 hours post-amphetamine for reporting.

Closest Location

University of PIttsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Disease or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical
Males or females between 18 and 55 years old
Fulfil DSM-5 criteria for cocaine use disorder
No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,)
No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, and MDMA as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991);
Not currently on prescription medical or psychotropic medications
Not currently pregnant or breastfeeding
No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines
No metallic objects in the body that are contraindicated for MRI
No baseline BP ≥ 140/90 and/or HR ≥ 100.

Patient Q&A Section

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

Who should consider clinical trials for disease?

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Most patients are not willing to participate in clinical trials and doctors often feel responsible for their patients' decisions. Physicians should be aware of the importance of patients' understanding of the risks and benefits of clinical trials and make an honest assessment of their willingness to consider enrollment, particularly in light of evolving evidence that participation in clinical trials may be associated with decreased survival.

Unverified Answer

Is post-amphetamine [c-11]npa pet scan typically used in combination with any other treatments?

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The addition of this treatment has the potential to enhance the tumour effects in a small subset of people, as indicated by a post-amphetamine PET scan performed with only a low number of scans. This should be considered in patients with unresectable disease requiring a PET as a therapeutic tool.

Unverified Answer

Have there been other clinical trials involving post-amphetamine [c-11]npa pet scan?

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[C- 11]NPA PET is a well-established method to scan for dopamine receptors after administration of the drug. We did see no evidence of positive or negative effects of (c-11)NPA on catecholamine turnover to c-NPA in the brain or on the behavioral effects of (c-11)NPA. Additional investigation is required to determine whether (c-11)NPA PET is a useful diagnostic tool before undertaking surgery for Pheochromocytoma.

Unverified Answer

What are the signs of disease?

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The signs of disease are numerous and vary from patient to patient. Some disease sign include; redness, swelling, pain, warmth, discharge, decreased range of motion.

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Can disease be cured?

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(Not to be interpreted as meaning the opposite of curable):<br>\nDisease cannot be cured. The cure rate for most diseases is approximately 10% or lower. Examples of diseases for which cure rates of 10% to 50% have been reported are bacterial and viral infections, and HIV disease. Most diseases of unknown cause have cure rates of approximately 10% to 50%. <br>\nFurthermore, disease severity cannot be reduced to a point where cure is possible. For example, Alzheimer disease cannot be cured in the strictest sense, although some clinical trials to treat the disease have been successful and there is a large body of evidence that current disease treatments are useful.

Unverified Answer

What is disease?

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Every society has its own definition of disease. Here, disease is treated as an objective biological phenomenon with specific biological etiologies. If the disease is identified before death, the biological etiology will have been demonstrated. If it is identified after death, the existence of the disease must be assumed, and further investigation is not included in this definition.

Unverified Answer

What are common treatments for disease?

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The most common treatment plan for diseases may include lifestyle modification to lessen symptoms, medication to treat symptoms, or surgery. There is no single most widely used treatment for disease because different disease circumstances are best treated with different treatment plans and treatment will be dictated by patient variables. Many conditions are very hard to treat and may require a combination of different treatment options before a full recovery occurs. The patient will always be the best guide in which treatment plan to follow.

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How many people get disease a year in the United States?

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About 4.7 million people in the US live a year with an acute illness—4.3 million new diagnoses and 1.4 million exacerbations. Nearly 1 out of 5 people who are hospitalized for an acute illness have been diagnosed with two or more chronic medical conditions such as asthma, diabetes, or arthritis. Diabetes had the highest number of cases with 1.4 million people, while asthma and arthritis had the lowest number of cases at 0.9 million and 0.9 million people, respectively. Most of the people who have been hospitalized for an acute illness have been diagnosed with more than one chronic condition. Those who also have asthma are at particularly high risk. Many chronic conditions that a patient has may also affect their health care use.

Unverified Answer

What causes disease?

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Many diseases of children and adults are not known to be determined by genetic predisposition as well as other environmental factors and must be seen in a holistic way.

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Is post-amphetamine [c-11]npa pet scan safe for people?

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Although the [c-11]npa PET scan seems to be a sensitive diagnostic modality, the use of amphetamine may result in increased [C]npa activity in some patients. This effect is more pronounced if administered orally rather than by injection, and hence this effect may represent a potential diagnostic dilemma. We consider that [C]npa PET scanning can be used carefully in patients with history of amphetamine use.

Unverified Answer

What is the primary cause of disease?

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Most commonly reported primary cause is autoimmune disease (62%), followed by infection (21%), and then neoplastic (16%). The majority of primary and secondary diagnoses were made on the basis of a diagnosis made by a physician, but in a few cases, the diagnosis was made on the basis of clinical examination and/or laboratory tests. Although many physicians were aware of the etiology of the disease, the study found that most reported it in primary correspondence with the reported primary cause. The physicians in the study were relatively well-trained and most used a standard set of diagnostic procedures.

Unverified Answer

How does post-amphetamine [c-11]npa pet scan work?

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PET imaging with [c-11]npa provides insight into biochemical mechanism(s) of acute drug effects, with potential to serve as a non-invasive functional imaging tool for the study of psychotropic drug action on the neuromodulator system.

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