NCT05558904 An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
| NCT ID | NCT05558904 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-01-19 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Lung nodule \>= 1 cm visualized by CT imaging * CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy * BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3 Exclusion Criteria: * Pregnancy * Diagnosis of diabetes * Current treatment with SGLT2 inhibitors or metformin
Contact & Investigator
Claudio Scafoglio, MD, PhD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05558904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05558904 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05558904 currently recruiting?
Yes, NCT05558904 is actively recruiting participants. Contact the research team at YCalzada@mednet.ucla.edu for enrollment information.
Where is the NCT05558904 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05558904 clinical trial?
NCT05558904 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Claudio Scafoglio, MD, PhD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 60 participants.