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64Cu-TRD2203 PET/CT Imaging in Patients With solid tumor

64Cu-TRD2203 PET/CT Imaging in Patients With solid tumor

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080394
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-01-29
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant tumor of digestive tract

Interventions

Index test:SUVmax, %ID, TlAC, residence time

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants who meet all of the following criteria are eligible for admission to this study: 1. A signed informed consent must be obtained before participating in the study. 2. Male or female patients =18 years old. 3. Histologically or cytologically confirmed digestive tumors (including but not limited to gastric, pancreatic, gallbladder, cholangiocarcinoma, hepatocellular carcinoma, colorectal cancer). 4. At least one lymph node, soft tissue, or visceral site metastasis has been confirmed or suspected. 5. ECOG score is 0-2. 6. Adequate organ function: bone marrow reserve: neutrophil count (ANC) = 1.5×10^9/L, platelet count =100×10^9/L, hemoglobin = 90g/L; Liver: total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0×ULN; Kidney: Serum creatinine (SCr) =1.5×ULN.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be admitted to the study: 1. Previously received radioligand therapy. 2. Female subjects who are pregnant or breastfeeding. 3. Are participating in any other clinical trial or have participated in a clinical trial within 28 days of receiving an investigational drug. 4. Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain the functional integrity of the nervous system. 5. Patients with other malignancies that may interfere with disease assessment, who have prior secondary malignancies that have been adequately treated, who have not received treatment for more than 3 years prior to enrollment, and who have no evidence of recurrence, are eligible to participate in the study. A combination of serious or poorly controlled medical conditions, including but not limited to an infection that is difficult to control, known active hepatitis B or C, or other conditions that the investigator believes may impair study participation or collaboration. 7. Physical or psychiatric history that may interfere with the purpose and evaluation of the study, or any condition in which the investigator determines that the patient is unable to cooperate with the imaging examination and procedure. 8. Patients who do not consent to the use of effective contraception or restrictive practices. 9. There are other conditions that the investigator deems unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Biodistribution analysis;

Secondary

MeasureTime frame
Radioactive absorbed dose analysis;

Countries

China

Contacts

Public ContactShiyu Lin

Affiliated Hospital of North Sichuan Medical College

shiyulin27@126.com+86 136 9620 7527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026