Using TROP-2 PET/CT for diagnosing solid tumors noninvasively
Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
This study is testing two new imaging agents to see if they can help diagnose different types of solid tumors, like pancreatic and breast cancer, without needing any invasive procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06203574 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and preliminary diagnostic efficacy of two imaging agents, [68Ga]Ga-NOTA-T4 and [18F]AlF-RESCA-T4, for noninvasive diagnosis of various solid tumors including pancreatic, breast, head and neck, and lung cancers. The approach integrates PET imaging with TROP-2-targeted therapies, aiming to enhance patient selection for targeted treatments and monitor their responses post-therapy. By focusing on TROP-2, the study seeks to provide a novel method for diagnosing these cancers more effectively.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with confirmed colorectal cancer.
Not a fit: Patients with severe hepatic or renal insufficiency or those who have undergone targeted therapy prior to the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment personalization for patients with solid tumors.
How similar studies have performed: Other studies utilizing PET imaging for cancer diagnosis have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be between 18 and 65 years of age and of either sex. 2. Patients with colorectal cancer confirmed by puncture or surgical pathology. 3. Written informed consent signed by the subject or legal guardian or caregiver. 4. Willingness and ability to cooperate with all programs of this study. Exclusion Criteria: 1. Severe hepatic or renal insufficiency; 2. Targeted therapy before radiotherapy or PET/CT scan； 3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range； 4. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.
Where this trial is running
Shanghai
- Huashan Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Fang Xie, PhD — Huashan Hospital
- Study coordinator: Yihui Guan, MD
- Email: guanyihui@hotmail.com
- Phone: 13764308300
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.