A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

NCT07689656 | Recruiting Phase 1

• 1 other identifier: Xlan-20260318
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \[⁶⁸Ga\]Ga-ELI421 injection in patients with prostate cancer. Secondary Objectives: To evaluate the biodistribution characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \[⁶⁸Ga\]Ga-ELI421 injection.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse Event (AE)

  Any abnormality, medication, or treatment after dosing shall be documented as an adverse event and concomitant medication / non-pharmacological treatment. All adverse events shall be followed up until resolution, stabilization or remission of symptoms, or until abnormal laboratory values return to normal, baseline or a stable state, or until a reasonable explanation is obtained (e.g., loss to follow-up, death).

  Day1, Day2-3

Secondary Outcomes (3)

• Lesion uptake value

  Day1

• Absorbed dose

  Day1

• Diagnostic performance

  Day1

Study Arms (1)

Single Arm with Dual PET Imaging: ELI421 and PSMA PET for Prostate Cancer

EXPERIMENTAL

Drug: [68Ga]Ga-ELI421 injection

Interventions

[68Ga]Ga-ELI421 injection DRUG

Administration Protocol: A single rapid intravenous bolus injection of \[68Ga\]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.

Single Arm with Dual PET Imaging: ELI421 and PSMA PET for Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
• Aged ≥ 18 years;
• In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Patients with histopathologically and/or cytologically confirmed prostate cancer;
• Has an indication for PSMA PET imaging;
• No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.
• Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.

You may not qualify if:

• Presence of comorbidities that may compromise subject safety or interfere with imaging results;
• Concomitant medications that may compromise subject safety or interfere with imaging results;
• Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
• Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
• Inability to complete PET imaging as required;
• Any other conditions deemed inappropriate by the investigator for participation in this study.

Sponsors & Collaborators

• Eli Radiopharma: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Xiaoli Lan

CONTACT

+86-2783692633; hzslxl@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)