SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization

NCT06389097 | Recruiting

• 3 other identifiers: J23152IRB00411454P01CA272222
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean absorbed dose to normal organs compared using different quantitative methods

  The mean absorbed dose to normal organs (e.g. kidney) will be calculated for each patient and compared using different quantitative reconstruction methods for SPECT imaging.

  48 months

Secondary Outcomes (2)

• Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images

  48 months

• Mean absorbed dose to normal organs correlated with toxicity

  48 months

Study Arms (2)

Cohort A

Patients with advanced prostate cancer planning to undergo treatment with Radium-223

Radiation: Radium-223

Cohort B

Patients with advanced cancer undergoing treatment with 177Lu-DOTATATE or 177Lu-PSMA-617

Radiation: 177Lu-DOTATATE; Radiation: 177Lu-PSMA-617

Interventions

Radium-223 RADIATION

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).

Cohort A

177Lu-DOTATATE RADIATION

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.

Cohort B

177Lu-PSMA-617 RADIATION

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.

Cohort B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hopkins/Affiliates inpatients, Hopkins/Affiliates outpatients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radium-223; lutetium Lu 177 dotatate; Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ana Kiess, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Kiess

CONTACT

443-287-7528; akiess1@jhmi.edu

Ryan Manuel

CONTACT

410-955-4261; rmanuel5@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)