Imaging Techniques for Lung Cancer

Overseen By Cynthia Phurrough, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cell>Point LLC

Disqualifiers: Current cancer treatment, Insulin-dependent diabetes, Pregnancy, Mental illness, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

154 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a new type of scan can detect lung cancer as well as the current standard scan. It focuses on patients likely to have lung cancer and uses a substance that makes cancer cells light up on the scan images.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing any current treatment for cancer, you would not be eligible to participate.

What data supports the effectiveness of the treatment 18 F FDG, 99m Tc ECDG for lung cancer?

Research shows that 18 F FDG, used in PET scans, is more accurate than traditional imaging methods for diagnosing and staging lung cancer, helping doctors plan better treatments and detect cancer spread more effectively. ^{1 2 3 4 5}

Is imaging with 18F FDG and 99m Tc ECDG safe for humans?

Imaging with 18F FDG and 99m Tc ECDG has been used in patients with lung cancer, and while the studies focus on their effectiveness, they do not report specific safety concerns. However, it's important to discuss any potential risks with your healthcare provider. ^{6 7 8 9 10}

How does the treatment 18 F FDG, 99m Tc ECDG differ from other lung cancer treatments?

The treatment using 18 F FDG and 99m Tc ECDG is unique because it involves advanced imaging techniques like PET scans, which help in accurately diagnosing and staging lung cancer by highlighting metabolic activity in the body. This approach is more precise than traditional imaging methods, allowing for better planning of treatments and assessment of therapy response. ^{1 2 11 12 13}

Research Team

Cynthia Phurrough, BS

Principal Investigator

Consultanat

Eligibility Criteria

This trial is for adults with confirmed lung cancer or strong clinical and CT evidence of it, who haven't started treatment yet. If they've had lung cancer before, they must have finished therapy at least 3 months ago. Participants need to agree to a tissue diagnosis if not already done.

Inclusion Criteria

I have confirmed lung cancer through a biopsy or CT scan.

I am not currently undergoing lung cancer treatment, or I finished my last treatment over 3 months ago.

If a tissue diagnosis of the primary lesion was not done prior to enrollment, the patient must agree to have a tissue diagnosis of the primary lesion within 15 days of the PET/CT study but prior to initiation of therapy, independent of the PET/CT results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Diagnosis

Participants undergo imaging with 99mTc-EC-DG SPECT/CT and 18F-FDG PET/CT to compare diagnostic accuracy

4-6 weeks

1 visit (in-person) for imaging

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 18 F FDG
• 99m Tc ECDG

Trial Overview The study compares two imaging techniques: SPECT/CT using a tracer called 99mTC-EC-DG versus PET/CT with the standard tracer 18F-FDG. It aims to see if SPECT/CT can match PET/CT in identifying primary and metastatic lung lesions.

Participant Groups

Group I: 99m Tc-EC-DG imaging agent Experimental Treatment 1 Intervention

99m Tc-EC-DG injection followed by SPECT/CT imaging (target of 20-30 mCi of Tc)and \< 1 mg EC-DG

Group II: 18-F-FDG Imaging Agent Active Control 1 Intervention

18 F FDG followed by PET/CT imaging

Who Is Running the Clinical Trial?

Cell>Point LLC

Lead Sponsor

Trials

5

Recruited

240+

Findings from Research

FDG-PET imaging is a valuable tool for diagnosing and staging lung cancer, helping to predict how well patients will respond to therapy and assess the aggressiveness of tumors.

Advancements in PET technology and the development of more specific radiopharmaceuticals are expected to enhance the management and treatment of lung cancer patients in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of FDG-PET scanning in lung cancer]. Sönmezoğlu, K.[2016]

References

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

PET scan in lung cancer: current recommendations and innovation. [2016]

2. Ireland pubmed.ncbi.nlm.nih.gov

Lung cancer and positron emission tomography with fluorodeoxyglucose. [2019]

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

Thoracic nodal staging with PET imaging with 18FDG in patients with bronchogenic carcinoma. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Impact of FDG-labelled positron emission tomography imaging on the management of non-small-cell lung cancer. [2019]

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

Imaging in lung cancer: positron emission tomography scan. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Radiation dosimetry and biodistribution of (99m)Tc-ethylene dicysteine-deoxyglucose in patients with non-small-cell lung cancer. [2021]

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

Imaging with 99mTc ECDG targeted at the multifunctional glucose transport system: feasibility study with rodents. [2016]

8. France pubmed.ncbi.nlm.nih.gov

[Results of FDG-PET scanning in the pre-operative staging of broncho-pulmonary tumors]. [2019]

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

Prospective use of serial questionnaires to evaluate the therapeutic efficacy of 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in suspected lung cancer. [2019]

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

Side Effects of Oncologic Treatment in the Chest: Manifestations at FDG PET/CT. [2021]

11. Poland pubmed.ncbi.nlm.nih.gov

[New imaging methods in diagnosis of lung cancer]. [2006]

12. Turkey pubmed.ncbi.nlm.nih.gov

[The use of FDG-PET scanning in lung cancer]. [2016]

13. France pubmed.ncbi.nlm.nih.gov

[PET scanning in the initial assessment of lung cancer]. [2016]