Recruiting

SPECT Imaging

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06389097

Conditions

Prostate Cancer

Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radium-223

177Lu-DOTATATE

177Lu-PSMA-617

Study Details

Brief 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.

Conditions

Prostate Cancer

Advanced Cancer

Study ID

NCT06389097

Start date

Feb 3, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 imaging protocol or that has schedule of procedures that would not be compatible with this protocol.
  • Patient unable to tolerate SPECT scan time, scan frequency, or position.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Radium-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).

177Lu-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.

177Lu-PSMA-617

177Lu-PSMA-617 will be given as per SOC or other clinical trial. It is typically infused intravenously over a period of 20-60 minutes.

Up to 6 cycles of 177Lu- PSMA-617 will be administered approximately every 6 weeks. Treatment cycle is defined as 6 consecutive weeks (D1-D42) following a dose of 177Lu- PSMA-617. Patients will receive up to six infusions of 7.4 GBq (200 mCi) every 6 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 approximately 15-22 minutes per field of view with two fields of view (45 min total) typically collected sequentially.

Primary outcome measure

  • Mean absorbed dose to normal organs compared using different quantitative methods [ Time Frame: 48 months ]

Central Contacts and Locations

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Radium-223
  • 177Lu-DOTATATE
  • 177Lu-PSMA-617
  • SPECT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-03-30.