New imaging method for detecting various cancers using a special probe
Comparison of 68Ga-GPFAPI-04 and 18F-FDG PET/CT in Patients With Malignant Tumors
NA · Guangdong Provincial People's Hospital · NCT06186427
This study is testing a new imaging method using a special probe to see if it can help doctors find different types of cancer earlier in patients who might have tumors, especially in those with digestive system cancers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06186427 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel fibroblast activation protein (FAP) ligand, DOTA-GPFAPI-04, which is radiolabeled with 68Ga for positron emission tomography (PET) imaging in patients suspected of having malignant tumors. The study aims to improve early detection and diagnosis of cancers, particularly in populations with high incidences of digestive system tumors. By utilizing advanced imaging techniques, the trial seeks to enhance the specificity and stability of tumor detection, potentially leading to better patient outcomes. Participants will undergo PET/CT scans to assess the effectiveness of this new imaging agent in identifying malignant tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with a high clinical suspicion of malignant tumors who have not yet undergone surgery or chemotherapy.
Not a fit: Patients who have recently undergone radiotherapy or chemotherapy, or those unable to tolerate biopsy procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early cancer detection and diagnosis, leading to better treatment outcomes for patients.
How similar studies have performed: Other studies utilizing targeted imaging agents have shown promise in improving cancer detection, suggesting that this approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with high clinical suspicion of malignant tumors; 2. Those who have undergone endoscopic biopsy or puncture biopsy indicating malignant tumors but have not undergone surgery or chemotherapy; 3. Previous history of malignant tumor surgery, suspected of recurrence or distant metastasis; 4. There is a willingness for puncture biopsy or surgery, and there are no contraindications for puncture biopsy or surgery, and there are no contraindications for anesthesia; 5. Sign an informed consent form and undergo a nuclear medicine examination, without any contraindications, with the ability and willingness to participate in the follow-up plan. Exclusion Criteria: 1. Those who cannot tolerate puncture biopsy or surgical contraindications; 2. Those who have undergone radiotherapy and chemotherapy in the past 3 months; 3. Individuals who are allergic to multiple drugs or foods; 4. Those who refuse nuclear medicine examinations; 5. Those who do not agree to sign an informed consent form and are unable or willing to follow up.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Malignant Neoplasm, Tumors, Metastatic Cancer, Fibroblast Activation Protein Targeting Probe, PET/CT, PET/MRI