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Trial Title:
177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors
NCT ID:
NCT06632873
Condition:
SSTR2 and Integrin αVβ3 Positive Tumors
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-TATE-RGD
Description:
accepted intravenous injection of 177Lu-TATE-RGD
Arm group label:
1.48-3.33 GBq of 177Lu-TATE-RGD
Summary:
Researchers has conducted extensive research on the treatment of neuroendocrine tumors
with 177Lu-EB-TATE and the treatment of FAP-expressing tumors with 177Lu-EB-FAPI, and
some researches have revealed 68Ga-TATE-RGD in imaging studies of neuroendocrine tumors
to find that the dual-targeted tracer showed an increasing TBR, suggesting the tracer
kinetic advantage of TATE-RGD; compared to the single-target tracer DOTATATE, the
dual-target TATE-RGD probe has a clear advantage in detecting liver metastases of NETs,
and it can be explored for potential therapeutic uses of TATE-RGD in future studies and
used for related companion diagnostics in targeted radioisotope therapy (RLT).
Detailed description:
Integrin αvβ3 is highly expressed in certain tumor cells and newly formed blood vessels,
making it an ideal target for diagnosis and treatment of integrin αVβ3 positive tumors.
177Lu-TATE-RGD is a novel drug developed independently in China, providing an effective
target for the treatment of integrin αVβ3 positive tumors. All patients underwent
whole-body 68Ga-TATE-RGD PET/CT screening within one week and received a single
intravenous injection of 1.48-3.33 GBq (40-100 mCi) 177Lu-TATE-RGD within one week. Blood
samples were collected from the vein in 1-2 mL volumes at 5 minutes, 3 hours, 24 hours,
72 hours, and 168 hours after injection to measure radioactivity. Then, whole-body planar
and SPECT/CT imaging was performed at 3, 24, 48, 72, 96, 120, and 168 hours after the
injection of 177Lu-TATE-RGD. The in vivo radiation dose of 177Lu-TATE-RGD was analyzed
and calculated, and the therapeutic effect and response were evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with clear pathological diagnosis and ineffective or progressing clinical
conventional treatment;
- tumor lesions with high SSTR2 and RGD untake confirmed on 68Ga-TATE-RGD PET/CT
within one week before the injection of 177Lu-TATE-RGD;
- signed written consent.
Exclusion Criteria:
- the exclusion criteria were a serum creatinine level of more than 150 μmol per
liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than
4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of
more than 3 times the upper limit of the normal range and a serum albumin level of
more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve
disease, a severe allergy or hypersensitivity to radiographic contrast material,
claustrophobia;
- any medical condition that in the opinion of the investigator may significantly
interfere with study compliance.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
+8613051615100
Email:
jialinx29@126.com
Start date:
September 1, 2024
Completion date:
February 20, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06632873
