BAMF Health Clinical Trials

Protocol Title: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Short Name: ECLIPSE Trial

Sponsor: Curium

Description: This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer.

The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 4 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment.

30 patients will participate in a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive SPECT imaging after each treatment cycle for dosimetry analysis. Sub-study participants will not be randomized.

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 400

Number of clinical sites in the US: 25 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: 64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Short Name: SABRE Trial

Sponsor: Clarity

Description: The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 50

Number of clinical sites in the US: 8 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: A Phase I/II Theranostic Study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identification and Treatment of GRPR-expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617

Short Name: COMBAT Trial

Sponsor: Clarity Pharmaceuticals Ltd

Description: The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 38 participants

Number of clinical sites in the US: 2 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma (FAPI-46 PDAC)

Sponsor: SOFIE Biosciences

Description: This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 60

Number of clinical sites in the US: 4 at present

Patient Eligibility Criteria:  please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: Evaluation of the clinical performance of key scanner features in the uPMR 790 PET/MRI system

Sponsor: UIH America, Inc (“United Imaging”)

Description: This project aims to evaluate the clinical performance of select features in the uPMR 790 scanner system through comparisons between new and previous generation sequence technology. Patients will be imaged using the uPMR 790 PET/MRI scanner system per routine scan protocols and routine BAMF Health procedures. The imaging data will subsequently be post-processed and analyzed. Patient participation is limited to the PET/MRI scan (up to 1.5 hours). Patients do not

Patient Enrollment at BAMF: Recruiting Now

Number of Patients to be enrolled: 20

Patient Eligibility Criteria:

INCLUSION CRITERIA

To be eligible to participate in this study, an individual must meet one the following criteria:

1. Any individual receiving a PET/CT on uEXPLORER at BAMF Health will be asked to receive a PET/MRI as part of this trial.
2. Any individual receiving a standard of care PET/MRI at BAMF Health and willing to undergo additional scanning unrelated to their clinically indicated PET/MRI.

To be eligible to participate in this study, an individual must meet all of these criteria:

1. Patients 18 years of age or older
2. Able to tolerate MRI scan times of up to 1.5 hours
3. Meet all BAMF MRI safety requirements

EXCLUSION CRITERIA

1. Individuals who are not willing or capable of giving informed consent or assent
2. Individuals with refractory claustrophobia
3. MRI safety considerations
4. MRI unsafe implants

• Non-removable piercings
• Unable to lay still
• Allergies against MRI contrast agents (exclusion criterion only for contrast-enhanced MRI)
• Additional special needs