Dual-Tracer Theranostic PET (NCT05680675) | Clinical Trial Compass
CompletedNot Applicable
Dual-Tracer Theranostic PET
United States50 participantsStarted 2022-12-08
Plain-language summary
This study is designed to obtain positron emission tomography with x-ray computed tomography (PET/CT) imaging data with each tracer pair, providing the imaging data needed to develop new simultaneous dual-tracer imaging techniques and processing algorithms for these tracer pairs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults aged 18 years or greater.
* willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
* presence of at least 1 measurable lesion ≥ 1 cm in size.
* willing to have their clinical records reviewed for at least 24 months after enrollment.
* willing to lie flat on their back in the PET/CT scanner for up to one hour to allow for the imaging data to be obtained.
* willing to undergo two separate PET/CT exams on different days within 2 weeks of each other.
* female participants who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging. This only applies to Arms 1 and 2, since only males will be included in Arm 3 (only males can get prostate cancer).
* Arms 1 and 2 only: known or suspected somatostatin receptor-positive neuroendocrine tumor (NET) who could be considered for clinical use of DOTATATE PET/CT imaging under the approved indications for use of this radiopharmaceutical according to published appropriate use criteria. These indications include initial staging after the histologic diagnosis of NET, evaluation of an unknown primary; evaluation of a mass suggestive of NET not amenable to endoscopic or percutaneou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has already completed recruitment — does that mean results or data might be available that could inform my treatment planning for neuroendocrine tumors or prostate cancer?
2Since this study focused on completing two PET/CT scans using dual tracers, what would those imaging findings actually show about my tumor, and how might that kind of information change my treatment options?
3This is listed as a theranostic study, meaning it seems to connect imaging with potential treatment — can you explain what 'theranostics' means for my specific diagnosis and whether this approach is something we should be pursuing?
4The trial is listed as Phase NA, which I understand might mean it was more of a diagnostic or imaging feasibility study rather than a treatment trial — so does that mean its main value is in guiding future therapy rather than providing a direct treatment benefit?
5Are there other active trials or standard-of-care imaging options that use similar PET tracer approaches for my condition, now that this particular study is closed to enrollment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm
Timeframe: PET/CT exams were obtained on two separate days within a two week span.