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Study of 99mTc-MIP-1404 SPECT/CT imaging compared to standard imaging methods for detecting lymph node metastases in patients with prostate cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on evaluating imaging methods for prostate cancer. The study compares different scanning techniques including SPECT/CT using a substance called 99mTc-MIP-1404, and other imaging methods like PET/CT using substances 18F-PSMA-1007 and Pylclari. These imaging methods are used to detect whether cancer has spread to lymph nodes or other parts of the body.

The main purpose is to determine if the new imaging method using 99mTc-MIP-1404 is better at finding cancer that has spread to nearby lymph nodes compared to current standard imaging methods. The study involves receiving an injection of one of these imaging substances through a vein, followed by body scanning. Each participant will undergo different types of scans to compare how well each method works in detecting cancer spread.

All imaging substances used in this study are specially designed to attach to cancer cells, making them visible during scanning. These scans help doctors understand if the cancer is confined to the prostate or has spread to other areas. This information is important for determining the most appropriate treatment approach for each person's specific situation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial imaging examination
You will receive an intravenous injection of one of the following imaging agents:
- 99mTc-MIP-1404 for SPECT/CT scanning
- 18F-PSMA-1007 for PET/CT scanning
- Pylclari solution for injection
The medical team will perform imaging scans to evaluate your prostate cancer status
Step 2
Comparative imaging procedures
Additional imaging procedures will be performed using different methods:
- CT scan with contrast enhancement
- Bone scan
- Magnetic resonance imaging (MRI) of the prostate
Step 3
Medical evaluation
The medical team will analyze all imaging results to:
- Assess the presence of cancer in the prostate
- Check if cancer has spread to lymph nodes
- Identify any potential bone involvement
The results will help determine the extent of the disease
Step 4
Follow-up period
Your participation in the study will continue until December 31, 2026
Regular assessments will be conducted to monitor your condition
The medical team will document any changes in treatment recommendations based on the imaging results

Who can join the trial?

8 criteria

You must be willing and able to provide written informed consent and follow all study requirements
You must be male and at least 18 years old
You must have confirmed high-risk prostate cancer with at least one of these characteristics:
- Gleason score of 4+4 or higher (a measure of how aggressive the cancer cells look under microscope)
- PSA level of 20 or higher (a blood test that measures prostate-specific antigen)
- Clinical stage T3a or higher (cancer that has grown outside the prostate)
- You may also qualify if you don't have confirmed prostate cancer yet, but have strong signs suggesting prostate cancer based on:
  - High PSA levels
  - Clinical findings during examination
  - Symptoms

Who cannot join the trial?

14 criteria

Age under 18 years old
Female patients (study is only for male participants)
Previous or current treatment with chemotherapy (medications used to treat cancer)
Known allergic reactions to imaging agents or contrast materials
Metastatic disease (cancer that has spread) outside the lymph nodes
Inability to lie still for the imaging procedures
Previous pelvic surgery (operations in the lower abdomen area)
Current participation in other clinical trials
Any medical condition that could interfere with the imaging procedures
Inability to provide informed consent
History of other cancers in the past 5 years (except for non-melanoma skin cancer)
Severe kidney or liver problems
Claustrophobia (fear of enclosed spaces) that would prevent imaging procedures
Metal implants or devices that could interfere with imaging

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Verified sites

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Verified
Turku University Hospital
Turku, Finland

Trial locations

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Investigated drugs

99mTc-MIP-1404 is a diagnostic imaging agent used in SPECT/CT scans. It is specifically designed to help detect and evaluate prostate cancer, particularly in identifying whether cancer has spread to lymph nodes. This radioactive tracer binds to a specific protein that is often present in prostate cancer cells, making them visible during imaging procedures. The trial compares this imaging method with conventional contrast-enhanced CT scanning to determine which method is better at detecting prostate cancer spread to nearby lymph nodes.

What is already known about the treatment

99mTc-MIP-1404 - A radioactive diagnostic imaging agent administered intravenously for SPECT/CT imaging, specifically developed for prostate cancer detection and staging. This radiopharmaceutical compound binds to prostate-specific membrane antigen (PSMA), which is typically overexpressed in prostate cancer cells, allowing for precise visualization of potential cancer spread and lymph node metastases. The substance belongs to the class of diagnostic radiopharmaceuticals and represents an advanced molecular imaging technique that offers potentially superior detection capabilities compared to conventional imaging methods for prostate cancer staging.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. It typically begins when cells in the prostate start to grow out of control. The cancer usually grows slowly and initially remains confined to the prostate gland. As the disease progresses, cancer cells may spread from the prostate to nearby tissues, lymph nodes, or other parts of the body. Early stages of prostate cancer often cause no noticeable symptoms. This condition becomes more common with age, particularly in men over 50.