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

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What is this study about?

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.

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

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

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

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 Study?

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
(In this case, a tissue sample must be taken to confirm the diagnosis after joining the study)

Who Cannot Join the Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Turku University Hospital	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.06.2022

Trial locations

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.

Investigated diseases:

Prostate cancer

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.

Trial ID:

2024-516083-28-00

NCT ID:

NCT06219746

Trial Phase:

Therapeutic use (Phase IV)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?