Gastric Cancer, Pancreatic Cancer
Conditions
Keywords
gastric cancer, pancreatic cancer
Brief summary
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[68Ga\]/ \[131I\]-IR199 in patients with Claudin 18.2 positive gastric cancer and pancreatic cancer.
Interventions
DRUG[68Ga]/ [131I]-IR199
\[68Ga\]/ \[131I\]-IR199, single dose
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver. 2. Age equal to or above 18 years old. 3. Histologically or cytologically confirmed gastric cancer or pancreatic cancer with Claudin 18.2 expression. 4. Must have ≥1 Claudin 18.2 positive lesions.
Exclusion criteria
1. Less than two weeks since the last treatment that could cause bone marrow suppression. 2. Known or suspected history of ≥3 grade renal and urinary system diseases. 3. Medical history of allergy, hypersensitivity reaction or intolerance to radioactive drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry | about 24 hours from time of injection, about 48 hours from time of injection and about 72 hours from time of injection | Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | From administration of [68Ga]/ [131I]-IR199 until 1 week after injection | Incidence and severity of adverse events (AEs) as assessed by CTCAE v6.0 |
Countries
China
Contacts
CONTACTYihui Guan, MD
Outcome results
None listed