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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two imaging techniques to determine if they reveal the same details for lung cancer. The study compares a new imaging method, SPECT/CT using 99mTc-EC-DG, against the standard PET/CT using 18F-FDG, to detect lung cancer lesions. Participants with confirmed or suspected lung cancer, based on previous tests, who are not currently receiving cancer treatment, qualify as good candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in lung cancer imaging.

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.

Is there any evidence suggesting that this trial's imaging techniques are likely to be safe?

Research has shown that 18 F-FDG, a common substance used in PET/CT scans, is generally safe for people. It is widely used in medical imaging and has a strong safety record.

For the investigational agent 99m Tc-EC-DG, earlier studies suggest it is also safe for imaging lung cancer. One study found that using 99m Tc-EC-DG was practical and safe, with a dose similar to what will be used in this trial. The radiation levels from 99m Tc-EC-DG in these studies were similar to other medical imaging tests, which are generally considered safe when used correctly.

Although any radioactive material carries risks, studies so far show it is well-tolerated, and no unexpected side effects have been observed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging techniques for lung cancer because they offer potentially more accurate and efficient diagnosis options. Unlike traditional imaging methods, which often rely on standard PET/CT scans, the 18 F FDG imaging agent is used with PET/CT to highlight areas of increased glucose metabolism, common in cancer cells, to better pinpoint tumors. Meanwhile, the 99m Tc ECDG imaging agent is distinctive because it combines with SPECT/CT imaging, potentially offering a different perspective by targeting glucose transporters and providing detailed images with less radiation exposure. These innovative approaches could lead to earlier and more precise detection of lung cancer, significantly impacting patient outcomes.

What evidence suggests that these imaging techniques are effective for lung cancer?

This trial will compare two imaging techniques for lung cancer: 18 F-FDG and 99m Tc-EC-DG. Research has shown that 18 F-FDG PET/CT scans are highly accurate in determining lung cancer stages, with one study finding an 87% accuracy rate in assessing cancer advancement. This accuracy aids doctors in understanding the cancer's severity. Meanwhile, early results suggest that 99m Tc-EC-DG, another imaging method under study, can also effectively image lung cancer, similar to 18 F-FDG. Both techniques provide clear images of the cancer, which is crucial for treatment planning. ^{6 7 8 9 10}

Who Is on the Research Team?

Cynthia Phurrough, BS

Principal Investigator

Consultanat

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11536524/

The role of baseline 18F-FDG PET/CT for survival ... Pretreatment baseline 18 F-FDG PET/CT-derived MTV might be a prognostic biomarker in NSCLC patients receiving immunotherapy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0001299825000145

Impact of [18F]FDG PET/CT Radiomics and Artificial ... demonstrated an impressive 87% accuracy in categorizing T1-T2 vs T3-T4 lung cancers using [18F]FDG PET/CT imaging data. Moreover, AI algorithms have shown ...

3. nature.com nature.com/articles/s41598-025-18677-5

The study of dual-phase 18F-FDG PET/CT-based models ... Dual-phase 18F-FDG PET/CT provides a set of delayed PET images that are additional to those obtained from routine 18F-FDG PET/CT, allowing for ...

4. jto.org jto.org/article/S1556-0864(25)00693-8/fulltext

Surveillance With Fluorine-18 Fluorodeoxyglucose ... Our study's findings and recent evidence challenge the idea that more intensive imaging in lung cancer surveillance ultimately leads to better patient outcomes.

5. jnm.snmjournals.org jnm.snmjournals.org/content/55/7/1062

Follow-up or Surveillance 18 F-FDG PET/CT and Survival ... The median survival of PET-positive and PET-negative groups was 32.9 and 81.6 mo, respectively (P < 0.0001). A subgroup analysis demonstrated a ...

6. lantheus.com lantheus.com/assets/technelite-oct20-2015-4-1.pdf

MATERIAL SAFETY DATA SHEET It is a radioactive isotope of. Technetium (Tc-99m). This product can cause: allergic reactions, anaphylaxis, tearing, radioactive material: may cause cancer, ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/48/supplement_2/354P.1

Evaluation of Tc-99m-EC-DG in lung cancer patients The average total body absorbed dose was 2.35-03 mGy/MBq (2.61E-01 cGy/1110 MBq). Radiation exposure of Tc-99m-EC-DG to whole body, blood- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5875059/

Noninferiority of 99mTc-Ethylenedicysteine-Glucosamine ... A Phase 2 study was conducted to compare 18F-FDG PET/CT and 99mTc-EC-G SPECT/CT in the detection and staging of patients with non-small cell lung cancer (NSCLC) ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2758190/

Radiation dosimetry and biodistribution of 99mTc-ethylene ... Imaging of primary NSCLC tumors with 9.25×102 MBq (25 mCi) of 99mTc-EC-DG appears to be feasible and safe. The effective dose equivalent for 1,110 MBq (30 mCi) ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01394679

A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET ... The purpose of this study is to determine if the images of the primary lesions of lung cancer and any metastatic lesions seen from the investigational ...