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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: 68Ga-XMFH01 PET/CT for Prostate Cancer (Diagnosis)

This study aims to measure 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.

Official registry: https://clinicaltrials.gov/study/NCT07885423 · The First Affiliated Hospital of Xiamen University · enrollment listed as 25

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 68Ga-XMFH01 PET/CT. The registry lists allocation as na. This study aims to measure 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.

They plan to enroll about 25 people at Xiamen. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Clinical Evaluation of the ACP3-Targeted Dual-Modality PET/Fluorescence Imaging Probe 68Ga-XMFH01 for Preoperative Imaging and Intraoperative Surgical Guidance in Prostate Cancer

Interventions: 68Ga-XMFH01 PET/CT

Primary outcome (registry wording): Diagnostic efficacy

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • 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 are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations

Public study contact (from the registry)

Liang Zhao, MD

18818350620

wzhaoliang01@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07885423 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07885423?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07885423?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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