68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Bombesin.

PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces.

The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue.

It had 1 arm (groups): 68Ga-DOTA-Bombesin PET/MRI (experimental).

Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

The registry classes the interventions as drug and procedure.

More on the Plan

To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE: Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.

After completion of study, patients are followed up at 24 hours and 1 week.

Who Took Part

The registry lists 10 actual participants took part.

It was open to men only aged from 19 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provides written informed consent. Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) \> 2 ng/mL\]. Able to remain still for duration of each imaging procedure (about one hour).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: unable to provide informed consent; inability to lie still for the entire imaging time; inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Bombesin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-04 with completion listed for 2015-06-30.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Normal Biodistribution of 68Ga-DOTA-Bombesin (time frame: 1 hour).

It also tracked 1 secondary outcome, for example 68Ga-DOTA-Bombesin Feasibility.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Bombesin in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Bombesin compound page, all human trials.