89Zr-DFO-Mirvetuximab PET/CT Imaging for Companion Diagnosis and Response Evaluation in Ovarian Cancer

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07790939
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-DFO-Mirvetuximab PET/CT — OTHER
    Two weeks prior to the start of the trial, laboratory test results including complete blood count, urinalysis, blood biochemistry, and electrocardiogram, as well as imaging findings, will be collected. Within one week after trial initiation, one ¹⁸F-FDG PET scan (at 1 h post-injection) and three ⁸⁹Zr-DFO-Mirvetuximab PET scans (at 24 h, 72 h, and 144 h post-injection) will be performed. Two months after trial completion, pathological examination results will be obtained and compared with the PET imaging findings

Study Details

Epithelial ovarian cancer (EOC) is the fifth leading cause of cancer-related death in women, with approximately 320,000 new cases and 200,000 deaths annually worldwide, and its incidence is rising. Current treatment mainly relies on surgery, chemotherapy, and radiotherapy, but EOC frequently develops platinum resistance and recurrence. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), was approved by the FDA in 2024 for FRα-positive, platinum-resistant EOC. However, it carries significant toxicities (ocular, interstitial lung disease, peripheral neuropathy) and a modest objective response rate of 33%, with rapid acquired resistance, underscoring the need for patient selection and response prediction via targeted imaging. FRα, a GPI-anchored cell-surface glycoprotein encoded by FOLR1, is minimally expressed in normal adult tissues but overexpressed in various epithelial tumors, including ovarian cancer. Its overexpression promotes invasion, metastasis, and potentially drug resistance, making it a promising theranostic target. While ¹⁸F-FDG PET/CT is widely used, it has limitations in detecting low-activity or small lesions and shows suboptimal sensitivity/specificity for nodal metastases. Radiolabeled folate probes (e.g., ⁹⁹ᵐTc-EC20) have demonstrated excellent FRα-targeting and clinical utility in selecting patients for FRα-directed therapies. Our team has developed ⁸⁹Zr-DFO-Mirvetuximab by conjugating the anti-FRα monoclonal antibody with the chelator p-isothiocyanatobenzyl-desferrioxamine B and radiolabeling with ⁸⁹Zr. Preclinically, this probe exhibited favorable stability, safety, and specific targeting of FRα-high tumors in xenograft models. Building on these results, we plan a clinical study enrolling 20 patients with newly diagnosed stage IV or first-recurrent EOC, who will undergo both ⁸⁹Zr-DFO-Mirvetuximab PET/CT and ¹⁸F-FDG PET/CT. The study aims to correlate radiotracer uptake with FRα expression and to demonstrate the superior performance of ⁸⁹Zr-DFO-Mirvetuximab in identifying and delineating ovarian cancer lesions compared to ¹⁸F-FDG

Key Dates

First listed
Aug 27, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 89Zr-DFO-Mirvetuximab PET/CT for Companion Diagnosis and Response Evaluation

Primary Outcome Measure

Standardized Uptake Value (SUV) of target or suspected tumor lesions in ovarian tumor for 89Zr-DFO-Mirvetuximab and 18F-FDG across imaging time points [ Time Frame: 1 week ]

Central Contacts

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