Me-4FDG PET/CT Scan for Lung Cancer

Recruiting at 1 trial location

Overseen By Yesenia Calzada

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: SGLT2 inhibitors, Metformin

Disqualifiers: Pregnancy, Diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-\[(18)F\]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.

Will I have to stop taking my current medications?

If you are currently taking SGLT2 inhibitors or metformin, you will need to stop these medications to participate in the trial.

Is Me-4FDG PET/CT Scan for Lung Cancer safe for humans?

There is a report of an allergic reaction, including low blood pressure, after using a similar tracer, [(18)F]FDG, which is used in PET scans. This suggests that while generally considered safe, there may be rare cases of allergic reactions. ^{1 2 3 4 5}

How is the drug Me-4FDG different from other treatments for lung cancer?

Me-4FDG is a novel imaging agent used in PET/CT scans for lung cancer, designed to selectively accumulate in malignant tissues, potentially offering more specific tumor detection compared to the commonly used FDG, which can also accumulate in non-cancerous conditions. ^{6 7 8 9 10}

Research Team

Claudio Scafoglio

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 with lung nodules seen on CT scans. It's open to those with confirmed lung adenocarcinoma and also to those with nodules considered benign. People can't join if they're taking diabetes medications like SGLT2 inhibitors or metformin, have a diabetes diagnosis, or are pregnant.

Inclusion Criteria

My lung nodules are considered benign with a lung-RADS score of 1-3.

My lung cancer is confirmed to be adenocarcinoma.

You have a lung spot that is at least 1 cm in size seen on a CT scan.

Exclusion Criteria

I am currently taking SGLT2 inhibitors or metformin.

I have been diagnosed with diabetes.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Me-4FDG tracer intravenously and undergo PET/CT over 15 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside

Trial Overview The study tests a new PET scan using Me-4FDG, a radioactive glucose tracer that helps detect cancer by showing where glucose is absorbed in the body. The goal is to see how well this new method works for early detection of lung cancer compared to current techniques.

Participant Groups

Group I: Diagnostic (Me-4FDG PET/CT) Experimental Treatment 4 Interventions

Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Lungevity Foundation

Collaborator

Trials

3

Recruited

180+

LUNGevity Foundation

Collaborator

Trials

8

Recruited

1,600+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

The synthesis of 2-Deoxy-2-(18)F-fluoro-d-mannose ((18)F-FDM) was successfully achieved with high radiochemical yields (50%-68%) and excellent purity (97.6%-98.7%), making it a viable candidate for tumor imaging.

In vivo studies showed that (18)F-FDM had significant tumor uptake (2.17 ± 0.32 %ID/g) and lower brain uptake (1.42 ± 0.10 %ID/g) compared to (18)F-FDG, suggesting it could provide clearer images of tumors while minimizing background noise from the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo characterization of 2-deoxy-2-18F-fluoro-D-mannose as a tumor-imaging agent for PET. Furumoto, S., Shinbo, R., Iwata, R., et al.[2016]

The newly developed tracer 2-deoxy-2-[(18)F]fluorosorbitol ((18)F-FDS) shows promising tumor uptake and contrast in brain imaging, particularly in models of brain tumors, with a significant uptake of 4.54%ID/g at 30 minutes post-injection.

(18)F-FDS demonstrates minimal accumulation in normal brain tissue, which enhances its ability to distinguish tumors from healthy areas, making it a potential alternative to FDG for detecting brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The synthesis of 18F-FDS and its potential application in molecular imaging. Li, ZB., Wu, Z., Cao, Q., et al.[2021]

This report highlights the first documented case of hypotension and anaphylaxis following the injection of [(18)F]FDG, a commonly used PET imaging agent, indicating potential serious allergic reactions beyond previously known skin manifestations.

While [(18)F]FDG is widely used for cancer and neurological imaging, this case emphasizes the need for awareness of its pharmacological effects and the importance of monitoring patients for adverse reactions during and after administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unusual case of anaphylaxis after fluorine-18-labeled fluorodeoxyglucose injection. Lee, DY., Lee, JJ., Kwon, HS., et al.[2021]

The synthesis of 2-deoxy-2-[18F]fluoro-D-glucopyranosyl [18F]fluoride was achieved with a radiochemical yield of approximately 28% in a total synthesis time of 70 minutes, indicating a relatively efficient process for producing this compound.

Biodistribution studies in mice showed that the compound defluorinates in vivo to produce 2-deoxy-2-[18F]fluoro-D-glucose and [18F]fluoride, suggesting potential applications in imaging or therapeutic interventions involving glucose metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and biodistribution of 2-deoxy-2-[18F]fluoro-D-glucopyranosyl [18F]fluoride in mice. Shiue, CY., Arnett, CD., Wolf, AP.[2019]

The study presents two cases of canine cancer (osteosarcoma and mammary carcinoma) where the novel radiopharmaceutical 18F-2-fluoro-2-deoxy-D-glucose (FDG) effectively accumulated in the tumors, indicating its potential as a cancer-seeking agent.

The tumor-to-control radioactivity ratios were significantly high (2.8 for osteosarcoma and 2.2 for mammary carcinoma) and remained stable over time, suggesting that FDG could be a reliable tool for cancer imaging in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of canine cancers with 18F-2-fluoro-2-deoxy-D-glucose (FDG) suggests further applications for cancer imaging in man. Paul, R., Johansson, R., Kiuru, A., et al.[2019]

FDG-PET is an effective noninvasive imaging technique for detecting and staging non-small-cell lung cancer, helping to reduce the need for invasive histopathological procedures.

While FDG-PET is sensitive, it is not tumor-specific and can lead to false positives due to accumulation in nonmalignant conditions; combining it with CT imaging improves staging accuracy for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-Art FDG-PET imaging of lung cancer. Gilman, MD., Aquino, SL.[2019]

(18)F-FDG PET/CT is a valuable imaging tool that combines metabolic and anatomical information, enhancing the management of lung cancer patients throughout various stages of care.

The review highlights its effectiveness in critical areas such as diagnosis, staging, therapy planning, and assessing treatment responses, making it essential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present and future roles of FDG-PET/CT imaging in the management of lung cancer. Kitajima, K., Doi, H., Kanda, T., et al.[2018]

Positron emission tomography (PET) using the radiopharmaceutical 18F-2-deoxy-D-glucose (FDG) is a valuable noninvasive tool that enhances the evaluation of lung cancer beyond traditional imaging methods like CT and MRI.

FDG-PET is effective for various applications in lung cancer management, including detecting tumors, staging the disease, monitoring for recurrence, and assessing patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography imaging in lung cancer. Patz, EF., Erasmus, JJ.[2019]

FDG-PET imaging has become an important tool for diagnosing and staging non-small cell lung cancer, gaining acceptance and reimbursement in many European countries over the past five years.

Further validation through large-scale studies is needed to confirm the effectiveness of FDG-PET in improving treatment outcomes, survival rates, and cost-effectiveness in lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of positron emission tomography with 18F-fluoro-2-deoxy-D-glucose in respiratory oncology. Vansteenkiste, JF., Stroobants, SG.[2019]

18FDG-PET demonstrated 100% sensitivity and 75% specificity in diagnosing solitary pulmonary nodules, making it a highly effective tool for identifying malignancies compared to traditional imaging methods.

In staging non-small-cell lung cancer, PET outperformed CT with 100% sensitivity and 93.3% specificity, revealing additional visceral metastases that CT missed, thus enhancing treatment planning and follow-up for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of Pet-18FDG in lung cancer]. Richter, JA., Torre, W., Gámez, C., et al.[2016]

References

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

In vitro and in vivo characterization of 2-deoxy-2-18F-fluoro-D-mannose as a tumor-imaging agent for PET. [2016]

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

The synthesis of 18F-FDS and its potential application in molecular imaging. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

An unusual case of anaphylaxis after fluorine-18-labeled fluorodeoxyglucose injection. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Synthesis and biodistribution of 2-deoxy-2-[18F]fluoro-D-glucopyranosyl [18F]fluoride in mice. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Imaging of canine cancers with 18F-2-fluoro-2-deoxy-D-glucose (FDG) suggests further applications for cancer imaging in man. [2019]

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

State-of-the-Art FDG-PET imaging of lung cancer. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Present and future roles of FDG-PET/CT imaging in the management of lung cancer. [2018]

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

Positron emission tomography imaging in lung cancer. [2019]

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

The role of positron emission tomography with 18F-fluoro-2-deoxy-D-glucose in respiratory oncology. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

[Value of Pet-18FDG in lung cancer]. [2016]