Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06632873

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Zhaohui Zhu, MD

CONTACT

[email protected]

+8613051615100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

177Lu-TATE-RGD

Drug

accepted intravenous injection of 177Lu-TATE-RGD

Primary outcomes

  1. StandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.

    Time frame: through study completion, an average of half-year

    The 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 outcomes

  1. Adverse events collection

    Time frame: 2 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaohui Zhu, MD

CONTACT

[email protected]

13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.