PET Imaging with FNP-59

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Benjamin L Viglianti, M.D, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Benjamin Viglianti

Must not be taking: Steroids, OCP, ACE inhibitors, others

Disqualifiers: Pregnancy, Adrenal pathology, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 (\[18F\]FNP-59) to image the adrenal gland. Some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

Will I have to stop taking my current medications?

Yes, if you are in Groups 2 or 3, you must stop taking steroids, oral contraceptives, spironolactone, estrogen, androgen, progesterone, ACE inhibitors, ARBs, or hormone-like supplements.

What data supports the effectiveness of the drug [18F]FNP-59?

The research highlights the advantages of using fluorine-18 labeled compounds in PET imaging, such as improved image quality and diagnostic accuracy, which are beneficial for cancer detection. Although specific data on [18F]FNP-59 is not provided, the general effectiveness of fluorine-18 labeled PET tracers in oncology suggests potential utility for this drug in imaging applications. ^{1 2 3 4 5}

How does the drug FNP-59 differ from other treatments for imaging progestin receptor-rich tumors?

FNP-59 is unique because it uses a radiotracer labeled with fluorine-18 to specifically target and image progestin receptors in tissues, which can help visualize receptor-rich tumors like breast tumors using PET imaging. This approach is different from standard treatments as it provides a non-invasive way to assess tumor characteristics and receptor status. ^{6 7 8 9 10}

Research Team

Benjamin L Viglianti, M.D, Ph.D.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for healthy individuals without adrenal gland issues, who will undergo hormone manipulation, or those with abnormal adrenal hormone secretion. It's not for pregnant women, prisoners, people over 400 lbs, steroid users, or those on certain medications like OCPs and ACE inhibitors.

Inclusion Criteria

My adrenal glands are healthy and I have not been diagnosed with any adrenal diseases.

You have abnormal hormone levels from your adrenal glands.

Exclusion Criteria

Pregnancy

I can give my own consent to participate.

Prisoners are not eligible

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging and Hormone Manipulation

Participants undergo an initial FNP-59 scan and hormone manipulation (dexamethasone or cosyntropin) for Groups 2 and 3.

4 days

2 visits (in-person)

Follow-up Imaging

Participants undergo follow-up FNP-59 scans to assess changes in uptake.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures.

4 weeks

Treatment Details

Interventions

• [18F]FNP-59 (Diagnostic Imaging Agent)

Trial Overview The study tests a new PET/CT scan using [18F]FNP-59 to image the adrenal gland. Some participants will also receive Cosyntropin (Group 3) or Dexamethasone (Group 2) to see how these drugs affect imaging results.

Participant Groups

Group I: Dexamethasone (Group 2) Experimental Treatment 2 Interventions

Participants will undergo an FNP-59 scan on day 0 in the am. Participants will then take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production. Participants will then have a second FNP-59 scan on day 4 in the am.

Group II: Cosyntropin (Group 3) Experimental Treatment 2 Interventions

Participants will undergo an FNP-59 scan on day 0 in the am. On day 4 the participant will arrive for imaging. Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.

Group III: Adrenal pathology (Group 4) Experimental Treatment 1 Intervention

Whole-body PET/CT scans will be done on 4 patients at 1 hr and the other 4 patients at 6 hours. All the patients will have a whole-body PET/CT scan at 3 hours.

Who Is Running the Clinical Trial?

Benjamin Viglianti

Lead Sponsor

Trials

2

Recruited

30+

Findings from Research

Fluorodeoxyglucose (FDG) is a widely used PET imaging agent for cancer detection, but it can produce false positive and false negative results in certain clinical situations.

Research is ongoing to develop new PET tracers, particularly fluorinated compounds, to improve accuracy in cancer imaging and potentially replace FDG in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond FDG: novel PET tracers for cancer imaging. Hicks, RJ.[2021]

Positron emission tomography (PET) is a rapidly advancing imaging technique that allows for noninvasive visualization and measurement of biological processes in cancer patients, enhancing clinical management.

While the widely used [(18)F]FDG-PET is effective for various cancer assessments, the development of target-specific PET tracers over the past decade offers more precise insights into cancer biology and progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography imaging of cancer biology: current status and future prospects. Chen, K., Chen, X.[2021]

Positron emission tomography/computed tomography (PET/CT) is a rapidly growing imaging technique in cancer management, but the commonly used radiotracer [(18)F]fluorodeoxyglucose (FDG) is not specific for malignant disease, highlighting the need for more tumor-specific PET radiopharmaceuticals.

Over the past 15 years, various alternative (18)F-labeled radiotracers have been developed and evaluated, which may provide better characterization of tumor biology, emphasizing the importance of regulatory compliance and safety in their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. Vallabhajosula, S.[2022]

18F-labeled PSMA-targeted PET imaging agents for prostate cancer offer significant advantages over traditional 68Ga-labeled compounds, including better availability in smaller hospitals and potential cost savings due to easier distribution.

These 18F-labeled compounds provide improved image quality with higher positron yield and lower noise, enhancing the detection of subtle lesions and allowing for more flexible imaging protocols, which may lead to better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging. Werner, RA., Derlin, T., Lapa, C., et al.[2023]

FDG is currently the only fluorinated tracer used in clinical PET imaging, providing high-resolution images due to its ideal properties, including low positron energy and a suitable half-life for dynamic studies.

Recent advancements in the synthesis of fluorinated tracers, particularly using prosthetic group precursors, have led to the development of both generalist and specific tracers that may enhance PET imaging in cancer patients, potentially expanding beyond the capabilities of FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorinated tracers for imaging cancer with positron emission tomography. Couturier, O., Luxen, A., Chatal, JF., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Beyond FDG: novel PET tracers for cancer imaging. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Positron emission tomography imaging of cancer biology: current status and future prospects. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Fluorinated tracers for imaging cancer with positron emission tomography. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

21-[18F]fluoro-16 alpha-ethyl-19-norprogesterone: synthesis and target tissue selective uptake of a progestin receptor based radiotracer for positron emission tomography. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Three-step two-pot automated production of NCA [18F]FDOPA with FlexLab module. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

18F-FEAC and 18F-FEDAC: PET of the monkey brain and imaging of translocator protein (18 kDa) in the infarcted rat brain. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Neuroinflammation in Low-Level PM2.5-Exposed Rats Illustrated by PET via an Improved Automated Produced [18F]FEPPA: A Feasibility Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Radiosynthesis of [18F] N-(3-Fluoropropyl)-2-beta-Carbomethoxy-3-beta-(4-Bromophenyl) Nortropane and the regional brain uptake in non human primate using PET. [2019]