Single-Photon Emission Computed Tomography (SPECT) Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (SEEtoTREAT)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy.
Description
Radiopharmaceutical therapy (RPT) is an emerging systemic treatment modality that delivers radiation to targeted cells. Recently FDA approved RPT agents include Radium-223 for prostate cancer, 177Lu-DOTATATE for neuroendocrine cancers, and 177Lu-PSMA-617 for prostate cancer. RPT is currently being administered as weight-based or fixed activities for 4-6 cycles, and there is concern that this standardized regimen compromises the potential efficacy of this treatment modality. In large part, this is because rigorous, validated dosimetry methods are not in standard clinical use, especially for alp…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Cohort A: Patients with advanced prostate cancer planning to undergo treatment with Radium-223 * Cohort B: Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617 \*\*Eligible patients may be planning to undergo these treatments as part of standard of care or as part of another research protocol * Age \> 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Histologic confirmation of malignancy Exclusion Criteria: * Patient is participating in another research protocol that does not allow participation in this…
Interventions
- RadiationRadium-223
Radium-223 will be given as per standard of care or other clinical trial. It is typically administered intravenously via slow injection once every 4 weeks with a dosage of 55 kBq/kg per cycle. Patients typically receive up to six cycles unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment. Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. These will be performed at 2-4 hr, 24 hr, and 48 hr after any cycle of Radium-223. Protocol preference is for imaging with 2 cycles, ideally cycle 1 and cycle 6, but imaging with any one or two cycle(s) is acceptable. The imaging time at each time point is approximately 30 minutes per field of view with two fields of view (1 hr total) typically collected sequentially (i.e., without repositioning the patient on the imaging table).
- Radiation177Lu-DOTATATE
177Lu-DOTATATE to be given as Standard of Care (SOC) or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes with peptide co-infusion prior and during the infusion. Patients will receive 4 cycles of 177Lu-DOTATATE administered approximately every 8 weeks. Treatment cycle is defined as 8 consecutive weeks (D1-D56) following a dose of 177Lu-DOTATATE. Patients receive up to four infusions of 7.4 GBq (200 mCi) every 8 weeks unless unacceptable toxic effects occurred, disease progression is apparent, or the patient is unable or unwilling to adhere to treatment. Three SPECT/CT studies will be performed for research purposes after 2 cycles in patients who consent to participate in this imaging and dosimetry study. Lu-177 SPECT CT will be performed at 24 (D2), 48 (D3), and 96 (D5) of any cycle of therapy. Imaging time at each time point is \~ 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially.
- Radiation
Location
- Johns Hopkins UniversityBaltimore, Maryland