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177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors

Therapeutic Efficiency and Response to 177Lu-TATE-RGD in Patients With SSTR2 and Integrin αVβ3 Positive Tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06632873
Enrollment
10
Registered
2024-10-09
Start date
2024-09-01
Completion date
2025-02-20
Last updated
2024-10-15

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

Conditions

SSTR2 and Integrin αVβ3 Positive Tumors

Brief 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.

Interventions

DRUG177Lu-TATE-RGD

accepted intravenous injection of 177Lu-TATE-RGD

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
StandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.through study completion, an average of half-yearThe semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.

Secondary

MeasureTime frameDescription
Adverse events collection2 monthsAdverse events within 2 months after the injection and scanning of patients will be followed and assessed.

Countries

China

Contacts

Primary ContactZhaohui Zhu, MD
13611093752@163.com13611093752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026