Imaging Scans for Malaria

SR
Overseen ByShanan R Immel, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if imaging scans can detect malaria parasites in the body. Researchers will use PET/CT scans (18F-fluorodeoxyglucose-positron emission tomography/computed tomography), specialized x-ray machines, to identify malaria in individuals deliberately infected for a separate study. Healthy individuals aged 18 to 54, already enrolled in specific malaria studies, are invited to participate. Participants will undergo two or three scans over several weeks, followed by a health check-up. As an unphased trial, this study allows participants to contribute to groundbreaking research in malaria detection.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on drugs that might interfere with the imaging scans, like certain diabetes medications, you may need to stop them temporarily. It's best to discuss your specific medications with the trial team.

What prior data suggests that these imaging scans are safe for humans?

Research has shown that FDG PET/CT scans are generally well-tolerated. This imaging method allows doctors to examine the body, particularly for cancer diagnosis. The FDG tracer used in these scans is common in medical settings and is considered safe for most people.

Some side effects can occur, but they are usually mild. For instance, patients might feel some discomfort at the injection site. The body quickly eliminates the tracer, primarily through urine.

Other studies have used FDG PET/CT without major safety concerns. However, like any medical procedure, some risks exist. Patients should discuss any concerns with their doctor to understand how this might affect them personally.12345

Why are researchers excited about this trial?

Researchers are excited about using 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) scans for malaria because this imaging technique offers a non-invasive way to visualize and understand the infection in real time. Unlike traditional diagnostic methods that rely on blood tests and clinical symptoms, FDG-PET/CT can provide detailed images of how malaria affects the body, potentially leading to earlier and more precise detection. This innovative approach could enhance our knowledge of malaria's impact on organs and tissues, paving the way for improved treatment strategies in the future.

What evidence suggests that imaging scans are effective for locating malaria parasites?

Research has shown that a special type of scan called FDG-PET/CT effectively detects infections and inflammation in the body. One study found that this scan reliably identifies infection sites in very sick patients. Another study suggested it can detect changes in organs during the early stages of malaria, indicating its potential to locate malaria parasites in the body. In this trial, healthy volunteers co-enrolled in a Plasmodium vivax challenge model will undergo FDG-PET/CT scans to explore its potential in detecting malaria parasites. Overall, FDG-PET/CT has proven useful in diagnosing various diseases, supporting its potential to find malaria parasites.678910

Who Is on the Research Team?

SR

Shanan R Immel, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 54 who are already enrolled in specific NIH studies where they will be deliberately infected with malaria. Participants must be generally healthy and willing to undergo imaging scans and blood tests.

Inclusion Criteria

I am between 18 and 54 years old.
I am not at risk of pregnancy due to surgery, menopause, or my sexual practices.
Able to provide informed consent
See 4 more

Exclusion Criteria

I do not have diabetes or uncontrolled blood sugar that would affect my scan.
Pregnancy or lactation
Any other finding that would interfere with protocol adherence, safety assessment, ability to give informed consent, or increase risk of adverse outcome from study participation
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Imaging

Participants undergo a baseline FDG-PET/CT scan before controlled human malaria infection

1 day
1 visit (in-person)

Infection and Imaging

Participants are deliberately infected with malaria and undergo a second FDG-PET/CT scan at the expected time of peak parasitemia

2 weeks
1 visit (in-person)

Optional Imaging

Participants may undergo an optional third FDG-PET/CT scan approximately 3 and 1/2 weeks after the second scan

3.5 weeks
1 visit (in-person, optional)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up visit with blood draw and physical exam

3.5 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-fluorodeoxyglucose-positron emission tomography/computed tomography scan

Trial Overview

The study is testing whether PET/CT scans using a radioactive sugar tracer can help locate malaria parasites inside the body after controlled infection. Participants receive up to three scans at different times during their involvement.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Healthy Volunteers who are co-enrolled in a P. vivax CHMI studyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33881529/

Accuracy of 18-F Fluorodeoxyglucose Positron Emission ...

In this study, FDG PET/CT imaging had a high negative predictive value in detecting cervical lymph node metastasis in patients with newly ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1740697/

Positron emission tomography using fluorine-18- ...

Abstract. To evaluate the relationship between PET using 18F-fluorodeoxyglucose (FDG) and pathological findings and to compare indices obtained by FDG-PET, FDG ...

Diagnostic value of [18F]FDG PET/CT for detection ...

Conclusion. [18F]FDG PET/CT appears to be a reliable imaging tool for detecting infectious and inflammatory foci in critically ill patients. Its ...

Utility of Fluorodeoxyglucose Positron Emission ...

In the field of infectious diseases, FDG-PET has demonstrated utility as an indicator of therapeutic efficacy in experimental pulmonary ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10096967/

Positron emission tomographic imaging with ...

PET-FDG was accurate in predicting the malignancy of nodes in 91% of instances, whereas computed tomography was correct in 64%. The sensitivity, specificity, ...

Use of [18F]Fluorodeoxyglucose Positron Emission ...

[¹⁸F]Fluorodeoxyglucose positron emission tomography/computed tomography ([¹⁸F]FDG PET/CT) is a valuable imaging tool in the post-treatment ...

Real-world assessment of the clinical utility of whole body 18F ...

F-FDG PET/CT confirmed suspected prosthetic endovascular infection for 6/16 (38%) patients. In this study,18F-FDG PET/CT led to a clinical ...

F-18 Fluorodeoxyglucose Positron Emission Tomography

F-18 FDG PET/CT has become a key component in tumor evaluation and significantly affects patient care. This was shown by data obtained during ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36895156/

Findings from Positron Emission Tomography-Computed ...

Findings from Positron Emission Tomography-Computed Tomography with 18F-Fluorodeoxyglucose Uncover a Potential Marker of Nutritional Status ...

Positron emission tomography and magnetic resonance ...

To identify organ-specific changes stages of P. vivax infection, we performed 18-F fluorodeoxyglucose (FDG) positron emission tomography/magnetic … ...