a pilot study of [ga-68]psma pet/mri for the assessment of psma-positive tumors

Conditions: Prostate-specific Membrane Antigen Positive Tumors; Prostate Cancer; Breast Cancer; Lung Cancer

Summary: the purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (pet/mri) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called \[ga-68\]psma.

primary objective the primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (pet/mr) with \[ga-68\] prostate-specific membrane antigen (psma) for staging and treatment monitoring of psma expressing tumors. \[ga-68\]psma pet/mr findings will be compared with standard of care imaging, patient follow up, and histopathology if available. \[ga-68\]psma pet/mr will not be used to change the patients' treatment plan. investigators will assess pet/mr test-retest reproducibility and compare baseline \[ga-68\]psma pet/mr with pet/mr after initiation (within 2-6 weeks) of therapy and evaluate if \[ga-68\]psma is a suitable biomarker for treatment monitoring and assessment of early treatment response. secondary objectives * to compare early changes in pet biomarker (\[ga-68\]psma) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response). * to compare changes in mri signal intensities (multi-parametric mri) with treatment response assessed at completion of therapy. * to compare results from multi-parametric mr imaging with \[ga-68\]psma uptake. * to assess combinations of quantitative pet and mri metrics. study design patients, who enroll in this study, will undergo a baseline \[ga-68\]psma pet/mr to assess the level of \[ga-68\]psma tumor uptake. patients with positive \[ga-68\]psma tumor uptake (defined as \[ga-68\]psma uptake twice the background activity) who are receiving systemic therapy will undergo a further \[ga-68\]psma pet/mr 2-6 weeks after start of treatment. patients with positive \[ga-68\]psma tumor uptake will also be offered to participate in a test- retest study with a 2nd \[ga-68\]psma pet/mr prior to treatment. patients will therefore undergo a maximum of three \[ga-68\]psma pet/mr imaging procedures. the first two test-retest ga-psma-pet/mri will be performed on separate days to allow for radioactive decay. there will be no other (e.g. clinically indicated) pet scan performed on the same day of \[ga-68\]psma-pet/mri.

Eligibility criteria:
inclusion criteria: * patients with psma-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express psma * patients able to tolerate pet/mri scans * informed consent must be given and signed exclusion criteria: * subjects who do not meet the above mentioned inclusion criteria * subjects who refuse to give and/or sign the informed consent * patients who have a history of serious adverse events related to a previous mri or pet/ct * patients who are unable to undergo mri scanning due to exclusion by institutional mri restriction policies as mentioned in the standard institutional mri informed consent form * patients who are currently pregnant or breast feeding. a pregnancy test within 72 hours of the first pet/mri will be performed. * anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks. * renal insufficiency: elevated creatinine and/or glomerular filtration rate (gfr)\<40ml/min/1.7sqm (exclusion criterion only for contrast enhanced mri) * patients with a known allergy against any component of the contrast enhancing mr agent will not receive mr contrast agents. (exclusion criterion only for contrast enhanced mri)

Keywords: psma pet/mri