Prostate Cancer (Diagnosis)NCT07885423
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
A study testing 68Ga-XMFH01 PET/CT in people with Prostate Cancer (Diagnosis) and ACP3, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
This study aims to evaluate the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), ACP3, PET / CT
- What is being tested?
- 68Ga-XMFH01 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with prostate cancer who are scheduled to undergo surgical treatment;
- Adult patients (aged 18 years or older);
- No evidence of distant metastases (M0), including nonregional lymph node metastases, bone metastases, or visceral metastases, as determined by conventional imaging (bone scintigraphy, CT, or MRI) or PET/CT;
- Patients with regional pelvic lymph node metastases (N1) are eligible for inclusion;
- Patients who have been fully informed of their disease status, treatment options, and study procedures, and who voluntarily provide written informed consent;
- Patients who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations.
Who cannot join
- Patients who are unwilling or unable to provide written informed consent or cooperate with study procedures;
- Patients who are unable to tolerate PET/CT examinations;
- Patients who have previously received any of the following treatments for prostate cancer: (a) Systemic therapy: More than 2 months of androgen deprivation therapy (ADT) or conventional hormonal therapy, or any prior treatment with novel hormonal agents, chemotherapy, immunotherapy, or targeted therapy. (b) Local therapy: Prior pelvic radiotherapy or surgery for prostate cancer;
- Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Liang Zhao, 18818350620, wzhaoliang01@163.com
About this study
Official title: Clinical Evaluation of the ACP3-Targeted Dual-Modality PET/Fluorescence Imaging Probe 68Ga-XMFH01 for Preoperative Imaging and Intraoperative Surgical Guidance in Prostate Cancer
This study aims to evaluate the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.
Read the detailed description
68Ga-XMFH01 is a novel ACP3-targeted dual-modality imaging probe with promising potential for prostate cancer detection and intraoperative surgical guidance. In this prospective study, patients with newly diagnosed prostate cancer will undergo preoperative 68Ga-XMFH01 PET/CT for initial disease assessment. Tracer uptake in tumor lesions will be quantified using the maximum standardized uptake value (SUVmax). During surgery, fluorescence imaging will be performed to identify tumor lesions and assess surgical margin status. The concordance between fluorescence-based surgical margin assessment (positive or negative) and histopathological findings will be evaluated. Following surgery, the diagnostic accuracy of 68Ga-XMFH01 PET/CT will be assessed using histopathological findings from resected specimens as the reference standard. The feasibility and safety of this dual-modality imaging approach will also be evaluated.
- Conditions
- Prostate Cancer (Diagnosis), ACP3, PET / CT
- Being tested
- 68Ga-XMFH01 PET/CT
- Keywords
- Prostate Cancer, ACP3, PET/CT
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-XMFH01 PET/CTDiagnostic test
Each participant will receive a single intravenous injection of 68Ga-XMFH01, a novel HER2-targeted radiotracer, followed by PET/CT imaging to noninvasively assess HER2 expression in tumor lesions.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-XMFH01 | Experimental | Participants will undergo preoperative 68Ga-XMFH01 PET/CT imaging for tumor detection and localization, followed by intraoperative fluorescence-guided surgical navigation using the same dual-modality probe. Receives: Diagnostic Test: 68Ga-XMFH01 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
Description: The sensitivity, specificity, and accuracy of 68Ga-XMFH01 PET/CT were calculated to evaluate the diagnostic accuracy.
Measured: 1 month
Secondary outcomes (2)
Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Prostate Surgical Margin Assessment
The concordance between intraoperative fluorescence imaging findings (positive or negative) and postoperative histopathological results (positive or negative) will be evaluated for prostate surgical margins.
Measured: 1 month
Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Pelvic Lymph Node Assessment
The concordance between intraoperative fluorescence imaging findings (positive or negative) and postoperative histopathological results (malignant or benign) will be evaluated for pelvic lymph nodes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885423
- Sponsor's protocol ID
- XMYY-2026KY213
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No